48-Hours of Antibiotics Reduced Infection Rate After C-Section in Obese Women

MedicalResearch.com Interview with:

Dr. Carri R. Warshak, MD Associate Professor of Obstetrics & Gynecology University of  Cincinnati

Dr. Warshak

Dr. Carri R. Warshak, MD
Associate Professor of Obstetrics & Gynecology
University of  Cincinnati

MedicalResearch.com: What is the background for this study?

Response: Cesarean deliveries are the most common major surgical procedure performed in the United States.  A common complication of cesarean section is wound infections that can include infections in the skin and incision site, or infections in the uterus itself after delivery.  These complications can lead to prolonged hospitalization after delivery for antibiotics and even further surgery in severe infections.  Often these wound complications lead to delayed healing, wound opening which can sometimes take several weeks to heal. Studies have demonstrated as many as 12% of women experience a surgical site infection after delivery.

Obesity is a strong risk factor for increased surgical site infections.  Increasing maternal weight increases the risk of wound complications, with a two to five fold increase in risk, making surgical site infections and common and concerning complication of cesarean delivery in obese women.

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FDA Approves BAXDELA™ (Delafloxacin) For Skin Infections

MedicalResearch.com Interview with:

Dr. Sue Cammarata, MD Chief Medical Officer Melinta Therapeutics

Dr. Cammarata

Dr. Sue Cammarata, MD
Chief Medical Officer
Melinta Therapeutics

MedicalResearch.com:   Would you explain what is meant by MRSA?

Response: MRSA is methicillin-resistant Staphylococcus aureus, a type of staph bacteria that is  resistant to many antibiotics. MRSA is noted by the CDC as one of the top 18 drug-resistant bacteria threats to the United States.  (from CDC https://www.cdc.gov/drugresistance/biggest_threats.html  ) 

MedicalResearch.com:   Why is infection with MRSA so serious?

Response:  MRSA can cause skin infections, lung infection and other issues.

If left untreated, MRSA infections can become severe and cause sepsis – a life-threatening reaction to severe infection in the body – and even death.  MRSA can also cause major issues, such as bloodstream infectionspneumonia and surgical site infections in a healthcare setting, such as a hospital or nursing home. “Resistance to first-line drugs to treat infections caused by Staphlylococcus aureus—a common cause of severe infections in health facilities and the community—is widespread. People with MRSA (methicillin-resistant Staphylococcus aureus) are estimated to be 64% more likely to die than people with a non-resistant form of the infection.”  (quote from WHO website http://www.who.int/mediacentre/factsheets/fs194/en/  )   Continue reading

20% of Hospitalized Patients Receiving Antibiotics Experience Side Effects

MedicalResearch.com Interview with:

Pranita Tamma, MD Assistant Professor Director, Pediatric Antimicrobial Stewardship Program Assistant Professor of Pediatrics Johns Hopkins Bloomberg School of Public Health

Dr. Pranita D. Tamma
Assistant Professor of Pediatrics
Director, Pediatric Antimicrobial Stewardship Program
The Johns Hopkins University School of Medicine 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: A study examining the impact of antibiotics prescribed for nearly 1500 adult patients admitted to The Johns Hopkins Hospital found that adverse side effects occurred in a fifth of them, and that nearly a fifth of those side effects occurred in patients who didn’t need antibiotics in the first place.

In the study, the researchers evaluated the electronic medical records of 1488 adults admitted to the general medicine services at The Johns Hopkins Hospital between September 2013 and June 2014. The patients were admitted for reasons ranging from trauma to chronic disease, but all received at least 24 hours of antibiotic treatment.

The researchers followed patients for 30 days after hospital discharge to evaluate for the development of antibiotic-associated adverse events. To determine the likelihood that an adverse reaction was most likely due to antibiotics and to identify how many adverse reactions could be avoided by eliminating unnecessary antibiotic use, two infectious disease clinicians reviewed all of the data.

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Outcomes of Hospital-Onset Multidrug Resistant Pseudomonas aeruginosa

MedicalResearch.com Interview with:

Sanjay Merchant, PhD Executive Director Center for Observational and Real-world Evidence (CORE) Merck

Dr. Merchant

Sanjay Merchant, PhD
Executive Director
Center for Observational and Real-world Evidence (CORE)
Merck

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In February, the World Health Organization (WHO) published its first ever list of antibiotic-resistant “priority pathogens” that pose the greatest threat to human health. The list highlights in particular the threat of gram-negative bacteria that are resistant to multiple antibiotics, referred to as multidrug-resistant (MDR) bacteria, which have built-in abilities to find new ways to resist treatment. MDR Pseudomonas aeruginosa (MDR PsA) is listed as one of the pathogens in the Critical category in terms of need for new therapies. It poses an urgent threat.

We set out to better understand the clinical and economic burden associated with hospital-onset MDR PsA so that appropriate treatment strategies can be employed to mitigate resistance. Our findings were presented at ASM Microbe 2017.

Mortality rates for hospital-onset MDR PsA patients (20.1%) were almost twice as high compared to patients who did not have MDR PsA (11.5%). The MDR PsA patient group had a significantly higher odds ratio for mortality even after controlling for various factors that may impact mortality.

Hospital-onset MDR PsA patients spent six additional days in the hospital when compared to patients who did not have MDR PsA infectionsThese findings highlight the public health threat of MDR PsA among hospitalized patients and the need for timely and effective therapy.

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Study Finds Single Antibiotic Cephalexin Alone Is Appropriate Outpatient Treatment For Cellulitis

MedicalResearch.com Interview with:
Gregory John Moran, MD, FACEP
Emergency Medicine Dept. & Infectious Diseases Service
UCLA Medical Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The bacterial etiology of cellulitis is difficult to determine because there is usually no material for culture, but streptococci are believed to be the most common etiology. Since the emergence of MRSA as a common cause of skin infections in the community, many clinicians add a second antibiotic with MRSA activity to an oral cephalosporin, such as a combination of cephalexin plus trimethoprim-sulfamethoxazole. It is unknown if there is an additional benefit to adding MRSA activity for treatment of cellulitis. This randomized, blinded trial compared cephalexin plus placebo to cephalexin plus trimethoprim-sulfamethoxazole for outpatient treatment of cellulitis without an abscess or wound.

Bottom line: We did not find a benefit from addition of trimethoprim-sulfamethoxazole.

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In Accordance With Guidelines, Fewer Low Risk Patients Receiving Antibiotics Before Dental Procedures

MedicalResearch.com Interview with:

Daniel C. DeSimone, M.D.</strong> Infectious Diseases Fellowship, Year 2 Mayo Clinic

Dr. DeSimone

Daniel C. DeSimone, M.D.
Infectious Diseases Fellowship, Year 2
Mayo Clinic

MedicalResearch.com: What is the background for this study?

Response: For over 50 years, the American Heart Association (AHA) has recommended antibiotics to be given to patients with certain cardiac conditions prior to invasive dental procedures (dental cleanings, extractions, root canals) with the hope to prevent infective endocarditis–a potentially deadly infection of the heart valves. Prevention of this infection was preferred to treatment of an established infection due to its high morbidity and mortality rates. However, in 2007, experts found that there was very little, if any, evidence that showed antibiotics prophylaxis prevented infective endocarditis prior to invasive dental procedures. Given this, the AHA revised its guidelines, significant reducing the number of patients where antibiotic prophylaxis would be given–as routine daily activities such as chewing food, tooth brushing, and flossing were much more likely to cause infective endocarditis than a single dental procedure.

For over 50 years, patients with cardiac conditions that placed them at “moderate risk” and/or “high risk” were to receive antibiotics prior to dental procedures. In 2007, the “moderate risk” group were to no longer receive antibiotic prophylaxis. This is a significantly large proportion of patients–approximately 90% of all patients who would have received antibiotic prophylaxis. Given the drastic changes made in 2007, there was concern among the medical and dental communities about whether we were leaving patients “unprotected” and at risk for infective endocarditis. Thankfully, several population based studies from our group and others across the United States have not shown an increase in the rate of infective endocarditis. However, the question remained, “Are providers following the 2007 AHA guidelines?” and “Are patients still receiving antibiotics prior to dental procedures when its no longer indicated by the guidelines?”.

This was the main focus of our paper. We were able to go into the local dental offices and at the same time, have full access to their medical records. Every dental visit between 2005 and 2015 at their dental office was reviewed; the type of dental visit, whether they received antibiotic prophylaxis or not. In addition, we could confirm their cardiac conditions that would place them at “moderate risk” or “high risk” compared to the general population.

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Antibiotic Failure in Community Acquired Pneumonia Surprisingly Common

MedicalResearch.com Interview with:

Dr. James A. McKinnell, MD LA BioMed Assistant Professor of Medicine David Geffen School of Medicine at UCLA

Dr. McKinnell

Dr. James A. McKinnell, MD
LA BioMed
Assistant Professor of Medicine
David Geffen School of Medicine at UCLA

MedicalResearch.com: What is the background for this study?

Response: Pneumonia is the leading cause of death from infectious disease in the United States. We conducted this study because current community-acquired pneumonia guidelines from the American Thoracic Society and the Infectious Disease Society America, published in 2007, provide some direction about prescribing antibiotics for community-acquired pneumonia. But large-scale, real-world data are needed to better understand and optimize antibiotic choices and to better define clinical risk factors that may be associated with treatment failure. Antibiotic failure for community-acquired pneumonia is associated with substantial morbidity and mortality and results in significant medical expenditures.

We examined databases containing records for 251,947 adult patients who were treated between 2011 and 2015 with a single class of antibiotics (beta-lactam, macrolide, tetracycline, or fluoroquinolone) following a visit to their physician for treatment for community-acquired pneumonia. We defined treatment failure as either the need to refill antibiotic prescriptions, antibiotic switch, ER visit or hospitalization within 30 days of receipt of the initial antibiotic prescription.

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Some Antibiotics Linked To Increased Risk of Miscarriage

MedicalResearch.com Interview with:

Anick Bérard PhD FISPE Research chair FRQ-S on Medications and Pregnancy and Director, Réseau Québécois de recherche sur le médicament (RQRM) and Professor, Research Chair on Medications, Pregnancy and Lactation Faculty of Pharmacy University of Montreal and Director, Research Unit on Medications and Pregnancy Research Center CHU Ste-Justine

Dr. Anick Bérard

Anick Bérard PhD FISPE
Research chair FRQS on Medications and Pregnancy
Director, Réseau Québécois de recherche sur le médicament (RQRM)
Professor, Research Chair on Medications, Pregnancy and Lactation
Faculty of Pharmacy, University of Montreal
Director, Research Unit on Medications and Pregnancy
Research Center, CHU Ste-Justine

MedicalResearch.com: The Danish study you cite reported a connection between antibiotics and miscarriage – why was further research of this topic necessary?

Response: Given that a single study will assess an association, repetition of findings are essential in order to assess causality. For example, we were able to conclude that smoking was causing lung cancer after 10 years of observational research on the topic showing concordant associations.

In addition, antibiotic prescription patterns vary from country to country, hence the importance of studying the research question in various patient populations.

Finally, our cohort has validated exposure status, gestational age (first day of pregnancy) and miscarriage cases – our study was also able to look at types of antibiotics.

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Antibiotics in Pregnancy Increase Children’s Risk of Otitis Media and Ventilation Tubes

MedicalResearch.com Interview with:
Hans Bisgaard, MD, DMSc

Professor of Pediatrics
The Faculty of Health Sciences
University of Copenhagen
Copenhagen University Hospital, Gentofte
Copenhagen, Denmark

MedicalResearch.com: What is the background for this study?

Response: The consumption of antibiotics is increasing worldwide. Antibiotics alter the maternal bacterial colonization and by vertical transmission this can affect the offspring. An unfavorable microbiome may increase the disease propensity of the offspring.
Otitis media is one of the most common infections in early childhood. We hypothesized that antibiotic consumption in pregnancy can increase the children’s risk of otitis media.
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Development and Assessment of BPX-01, a Novel Topical Minocycline Gel for Treatment of Acne Vulgaris


MedicalResearch.com Interview with:
Usha Nagavarapu, PhD

Senior director of preclinical drug development
BioPharmX

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Acne vulgaris is a complex chronic inflammatory disease known to be linked with P. acnes and can have profound social and psychological effects. Though a number of treatments exist, there is promise of a long-term benefit for acne patients. BioPharmX’s in vitro and in vivo studies have revealed that a low-dose, topical 1% minocycline gel (BPX-01) provided a localized and targeted delivery of adequate minocycline to the epidermis and pilosebaceous units that can potentially limit systemic exposure and may reduce treatment related side effects.

At the intended clinical dose, toxicity and safety animal studies found that BPX-01 was well tolerated with no significant local or systemic toxic effects. A comparative animal study with oral minocycline demonstrated that topical application of minocycline can limit systemic exposure while delivering sufficient minocycline to the skin to treat acne vulgaris.

Along the same lines, a 4-week clinical study with extended release oral minocycline to assess the skin and plasma concentrations of minocycline was conducted. A marked reduction of mean acne lesion counts from baseline was seen with oral minocycline with presence in plasma. On the contrary no minocycline was identified in the skin from periauricular biopsies.

Recently, BioPharmX completed a 4-week Phase 2 clinical repeat-dose study of BPX-01. The minocycline gel was well tolerated and over 90% of P. acnes were eliminated.

A 12-week Phase 2 dose-finding clinical trial to further assess the efficacy and safety of BPX-01 for the treatment of moderate-to-severe, non-nodular inflammatory acne vulgaris has been initiated. The dose-finding study will provide additional support for the planned Phase 3 clinical trial program with BPX-01.

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Severe Clostridium difficile Infections May Be Better Treated With Vancomycin

MedicalResearch.com Interview with:

Vanessa W. Stevens, PhD IDEAS 2.0 Center, Veterans Affairs (VA) Salt Lake City Health Care System Division of Epidemiology, Department of Internal Medicine University of Utah School of Medicine Salt Lake City, Utah

Dr. Vanessa Stevens

Vanessa W. Stevens, PhD
IDEAS 2.0 Center, Veterans Affairs (VA) Salt Lake City Health Care System
Division of Epidemiology, Department of Internal Medicine
University of Utah School of Medicine
Salt Lake City, Utah

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Although metronidazole remains the most commonly used drug to treat Clostridium difficile infection (CDI), there is mounting evidence that vancomycin is a better choice for some patients. Most previous studies have focused on primary clinical cure, but we were interested in downstream outcomes such as disease recurrence and mortality. We found that patients receiving metronidazole and vancomycin had similar rates of recurrence, but patients who were treated with vancomycin had lower risks of all-cause mortality. This was especially true among patients with severe Clostridium difficile.

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Childhood Antibiotic Use Linked To Higher BMI At Age 3

MedicalResearch.com Interview with:

Melissa N. Poulsen, PhD, MPH</strong> Postdoctoral Fellow Johns Hopkins Bloomberg School of Public Health Geisinger Center for Health Research

Dr. Melissa N. Poulsen

Melissa N. Poulsen, PhD, MPH
Postdoctoral Fellow
Johns Hopkins Bloomberg School of Public Health
Geisinger Center for Health Research

MedicalResearch.com: What is the background for this study?

Response: Several past studies report positive associations between early childhood antibiotic use (particularly in the first year of life) and body mass index (BMI) later in childhood. Studies have also observed positive associations with prenatal antibiotic use and BMI, but without information on childhood antibiotics, such studies cannot rule out an underlying causal relationship between prenatal antibiotic exposure and early childhood antibiotic use.

No study to date has concurrently evaluated prenatal and early childhood antibiotic exposure. We used mother-child linked electronic health record data to determine whether prenatal and childhood antibiotic use are independently associated with BMI at age 3 years.

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Infections in Infancy, Not Antibiotics Associated With Childhood Obesity

MedicalResearch.com Interview with:

De-Kun Li, MD, PhD Senior Research Scientist Division of Research Kaiser Foundation Research Institute Kaiser Permanente Oakland, CA 94612

Dr. De-Kun Li,

De-Kun Li, MD, PhD
Senior Research Scientist
Division of Research
Kaiser Foundation Research Institute
Kaiser Permanente
Oakland, CA 94612

MedicalResearch.com: What is the background for this study?

Response: The composition of gut microbia (microbiome) has emerged as a key contributor to human disease risk. The external influence on the composition of microbiome in early childhood, especially in infancy, has been linked to increased risk of childhood obesity. Several studies have examined use of antibiotics in infancy and reported an association between use of antibiotics and increased risk of childhood obesity. This has caused a great uncertainty among both pediatricians and parents regarding treatment of infant infections. However, the previous studies failed to separate the effect of underlying infections for which antibiotics were used from the effect of the antibiotics itself. The contribution of our study was to examine the effects of infections and antibiotic use separately.

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33% Rise In ‘Last-Resort’ Antibiotics Use in Hospitals

MedicalResearch.com Interview with:

James Baggs, PhD CDC

Dr. James Baggs

James Baggs, PhD
Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention
Atlanta, Georgia

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We used medical claims data to estimate the amount of antibiotics used in US hospitals from 2006 – 2012. Data came from the Truven Health MarketScan Hospital Drug Database, which included about 300 hospitals and more than 34 million discharges. Antibiotic use in hospitals was very common with more than half of patients receiving at least one antibiotic during their hospital stay. Overall rates of antibiotic use in U.S. hospitals did not change over time; however, there were significant changes in the types of antibiotics prescribed.

Importantly, the types of antibiotics with the largest increases in use were the types of antibiotics often considered to be the most powerful. Of particular concern, there was a 37% rise in the use of carbapenems, commonly referred to as “last resort” antibiotics.

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Food Allergies May Be Higher In Children Who Receive Antibiotics During First Year

MedicalResearch.com Interview with:

Bryan L. Love, PharmD, BCPS-AQ ID Associate Professor Department of Clinical Pharmacy & Outcomes Sciences South Carolina College of Pharmacy - University of South Carolina Columbia, South Carolina 29208-0001

Dr. Bryan Love

Bryan L. Love, PharmD, BCPS-AQ ID
Associate Professor
Department of Clinical Pharmacy & Outcomes Sciences
South Carolina College of Pharmacy
University of South Carolina
Columbia, South Carolina 29208-0001

MedicalResearch.com: What is the background for this study?

Response: In the US, food allergy has become one of the more common childhood medical conditions diagnosed in young children. Antibiotics are frequently prescribed in young children, and research continues to reveal that as many as 30% of antibiotic prescriptions are not appropriate.* We sought to examine if there was an association between antibiotic prescription and food allergy diagnosis.
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Study of Topical Minocycline For Acne Demonstrates No Phototoxicity or Absorption

MedicalResearch.com Interview with:
Kin F. Chan, PhD

Executive Vice President of Research and Technology
BioPharmX Corporation

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There were two studies in this series.  The purpose is to get a better understanding of the blood plasma and skin levels of minocycline in a relevant animal model (minipig) for both the oral form of minocycline (Solodyn) and topical BPX-01, and to elucidate the same for oral minocycline only in a clinical study.

The results provided valuable guidance and assurance to our upcoming Clinical Phase 2b dose-ranging study design.

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Preventing Bacteria From Sticking Would Eliminate Need For Antibiotics

MedicalResearch.com Interview with:

Dr Peter Monk BSc PhD Faculty Director of International Affairs Reader in Immunology Department of Infection, Immunity and Cardiovascular Disease Sheffield University Medical School

Dr. Peter Monk

Dr Peter Monk BSc PhD
Faculty Director of International Affairs
Reader in Immunology
Department of Infection, Immunity and Cardiovascular Disease
Sheffield University Medical School

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The tetraspanin proteins are found on the surface of all mammalian cells. The cell surface is the place where cells ‘socialise’: they talk to each other to coordinate activities, stick to each other to form tissues and sometimes crawl across each other to get to where they need to go. Tetraspanins have an important job to do in the organisation of the cell surface, amongst other things enabling the formation of ‘sticky patches’ (tetraspanin-enriched microdomains or TEM) that cause cells to adhere together or provide traction to allow movement. Some bacteria have evolved ways of hijacking the TEM for their own ends, adhering to tightly to these structures so that the normal things that sweep bacteria away (such as blood, sweat and tears!) are no longer effective. At this point, infection begins.

We have found that the TEM can be partly disrupted, by adding small parts of tetraspanins (peptides) to cells. The peptides seem to work by weakening the tetraspanin glue that holds the TEM together and causing the other components that give the ‘stickiness’ to the TEM to become more spaced out. We use the analogy of Velcro(TM), where the fabric hooks and loops are held together in woven material; loosen the weave and the hooks and loops fall apart, no longer able to engage strongly with the loops in the opposing piece of fabric.

Using reconstructed human skin, we were able to show that the tetraspanin peptides were both safe and effective; they did not affect wound healing in burned skin, but they could lower the bacterial load in the wound by 50%. This would allow the immune system (including the fluid that ‘weeps’ from wounds) to deal with the remaining bacteria more easily. Unlike conventional antibiotics that tend to kill bacteria, our peptides simply cause them to get washed away, so not invoking the evolutionary selective mechanisms that lead to resistance.

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Phase 2 Study of New Combination Antibiotics Successfully Treats Complicated UTIs

MedicalResearch.com Interview with:

Amanda Paschke, MD Director, Infectious Disease Clinical Research Merck Research Laboratories

Dr. Amanda Paschke

Amanda Paschke, MD
Director, Infectious Disease Clinical Research
Merck Research Laboratories

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Relebactam is an investigational beta-lactamase inhibitor being developed as a fixed-dose combination with imipenem/cilastatin, which is a broad-spectrum antibiotic in the carbapenem class. In preclinical studies, this combination demonstrated antibacterial activity against a broad range of multidrug-resistant Gram-negative pathogens, including those producing extended-spectrum beta-lactamases such as Klebsiella pneumoniae carbapenemase (KPC)-producing Enterobacteriaceae and AmpC-producing Pseudomonas aeruginosa. Many of the most concerning infections caused by “superbugs” are caused by Gram-negative bacteria. These bacteria have evolved to be resistant to commonly used antibacterials, and even to antibacterials used as “last resort” treatment, which is why finding ways to treat them has become urgent. The addition of relebactam to imipenem is designed to restore activity of imipenem against certain imipenem-resistant strains of Gram-negative bacteria known to cause serious infections among people who often have other underlying medical conditions, which complicates treatment.

This was a Phase 2, multicenter, randomized, double-blind, non-inferiority study. The study looked at the use of relebactam plus imipenem versus imipenem alone for the treatment of adult patients with complicated urinary tract infections. The primary endpoint for the trial was microbiological response at the completion of IV study therapy. The study met its primary endpoint, demonstrating that the combination of relebactam with imipenem was as at least as effective as imipenem alone for the treatment of complicated urinary tract infections. The trial also demonstrated that the combination of relebactam plus imipenem is well-tolerated, with a safety profile similar to that of imipenem alone in this patient.

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Antibiotics Increase Oxygen in Bowel, Allowing Salmonella To Thrive

MedicalResearch.com Interview with:

Andreas J. Bäumler, Ph.D Editor, Infection and Immunity Associate Editor, PLOS Pathogens Section Editor, EcoSal Plus Professor, Department of Medical Microbiology and Immunology Vice Chair of Research University of California, Davis School of Medicine Davis, California

Dr. Andreas Bäumler

Andreas J. Bäumler, Ph.D
Editor, Infection and Immunity
Associate Editor, PLOS Pathogens
Section Editor, EcoSal Plus
Professor, Department of Medical Microbiology and Immunology
Vice Chair of Research
University of California, Davis School of Medicine
Davis, California

 

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Bäumler: Antibiotics are generally beneficial for treating bacterial infection, but paradoxically a history of antibiotic therapy is a risk factor for developing Salmonella food poisoning.  Our study reveals the mechanism by which antibiotics increase susceptibility to Salmonella infection.

Antibiotics deplete beneficial microbes from the gut, which normally provide nutrition to the cells lining our large bowel, termed epithelial cells. Depletion of microbe-derived nutrients causes our epithelial cells to switch their energy metabolism from respiration to fermentation, which in turn increases the availability of oxygen at the epithelial surface. The resulting increase in oxygen diffusion into the gut lumen drives a luminal expansion of Salmonella by respiration. Through this mechanism, antibiotics help Salmonella to breath in the gut.

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CDC Estimates 47 Million Unnecessary Antibiotic Prescriptions Among US Outpatients Annually

MedicalResearch.com Interview with:

Dr. Fleming-Dutra MD CDC Dr. Fleming-Dutra MD is a medical epidemiologist with the Office of Antibiotic Stewardship in the Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention (CDC). She is also a pediatrician and pediatric emergency medicine physician and has focused on infectious diseases epidemiology and antibiotic stewardship in the outpatient setting in her career at CDC.

Dr. Fleming Dutra

MedicalResearch.com: What is the background for this study?

Dr. Fleming-Dutra: One of the most urgent public health threats of our time is the emergence of antibiotic-resistant bacteria. The use of antibiotics is the single most important factor leading to antibiotic resistance around the world.  Simply using antibiotics creates resistance.  To combat antibiotic resistance we have to use antibiotics appropriately — only when needed and, if needed, use them correctly.  In 2015, the White House released the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB), which set a goal for reducing inappropriate outpatient antibiotic use by 50% by 2020.  However, the amount of antibiotic use in the outpatient setting that is inappropriate was unknown.

MedicalResearch.com: What are the main findings?

Dr. Fleming-Dutra: In this study, we estimate that at least 30% of antibiotics prescribed in doctors’ offices, emergency departments and hospital-based clinics are unnecessary—meaning that no antibiotic was needed at all, which equates to 47 million unnecessary antibiotic prescriptions written annually in these outpatient settings.  Most of those unnecessary antibiotic prescriptions were written for acute respiratory conditions, a key driver of antibiotic overuse. Thus, in order to reach the White House goal of reducing inappropriate outpatient antibiotic use by 50%, a 15% reduction in overall antibiotic use in outpatient settings is needed by 2020.

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No Consensus on Antibiotic Prophylaxis Prior To Pediatric Surgery

MedicalResearch.com Interview with:

Thomas J. Sandora, M.D., M.P.H. Senior Associate Physician in Medicine; Hospital Epidemiologist; Medical Director, Infection Control Boston Children’s Hospital Associate Professor of Pediatrics, Harvard Medical School

Dr. Thomas Sandora

Thomas J. Sandora, M.D., M.P.H.
Senior Associate Physician in Medicine; Hospital Epidemiologist; Medical Director, Infection Control
Boston Children’s Hospital
Associate Professor of Pediatrics, Harvard Medical School

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Sandora: Giving antibiotics before certain types of operations results in lower rates of surgical site infections. However, there are limited data about which pediatric operations require antibiotic prophylaxis. We examined national variability in antibiotic prophylaxis for the 45 most commonly performed pediatric operations at children’s hospitals in the U.S. We found that antibiotic use was considered appropriate for only 64.6% of cases, with a high degree of variability within procedures and between hospitals.

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Antibiotics Don’t Promote Resistance Gene Transfers Between Cells

MedicalResearch.com Interview with:

Dr. Lingchong You PhD Paul Ruffin Scarborough Associate Professor of Engineering Duke University

Dr. Lingchong You

Dr. Lingchong You PhD
Paul Ruffin Scarborough Associate Professor of Engineering
Duke University

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. You: Horizontal gene transfer (HGT) refers to the transfer of genes between organisms of the same or different species other than reproduction. In bacteria, ​Horizontal gene transfer can occur through conjugation (bacterial mating), transduction mediated by phage, or transformation. During conjugation, a donor cell makes a copy of a conjugal plasmid and passes it to a recipient cell, turning it into a transconjugant.

It is well appreciated that HGT (particularly through conjugation) is the major mechanism underlying the wide spread of genes encoding antibiotic resistance.  Given this notion, it is tempting to assume that the use of antibiotics could increase the efficiency of horizontal gene transfer, creating a vicious cycle. Indeed, this has been speculated in the literature even though precise experimental measurements have been lacking.

In our study, we find that antibiotics covering all major classes do not promote the probability of conjugation between donor and recipient cells. Instead, antibiotics modulate the final outcome of conjugation dynamics by imposing different degrees of selection on the donor cells, recipient cells, and the transconjugants. Depending on the antibiotic doses and how the antibiotic affects the three populations, the selection dynamics could lead to an increase or the decrease in the frequency of transconjugants.

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Children Receive a Disproportionate Share of Antibiotic Treatment

MedicalResearch.com Interview with:
Ashley Bryce, NIHR PhD student
Centre for Academic Primary Care, University of Bristol (first author)
Dr Céire Costelloe
NIHR Health Protection Research Unit in Healthcare associated infections and AMR, Imperial College London (senior author)

 MedicalResearch.com: What is the background for this study?

Response: Antimicrobial resistance is an internationally recognised threat to health. Previous antibiotic use has been shown to be a risk factor for antimicrobial resistance in adults.

The contribution of primary healthcare is particularly important as this is where almost 80% of all antibiotics used within the health service are prescribed. Children receive a lot of primary healthcare services and, as such, receive a disproportionately high number of antibiotics compared with middle aged populations.

Despite this, little research has been published describing the prevalence of bacterial resistance in children or the risk factors of importance in this group.

MedicalResearch.com: What are the main findings?

Response: Prevalence of resistance to commonly prescribed antibiotics in primary care in children with urinary tract infections caused by E coli is high, particularly in countries outside the OECD, where one possible explanation is the availability of antibiotics over the counter. This could render some antibiotics ineffective as first line treatments for urinary tract infection. Routine use of antibiotics in primary care contributes to antimicrobial resistance in children, which can persist for up to six months after treatment.

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Fluoroquinolones Linked to Increase in Retinal Detachments

MedicalResearch.com Interview with:
Fanny Raguideau
Evaluateur en pharmaco-épidémiologie
Direction Scientifique et de la Stratégie Européenne
Pôle Epidémiologie des produits de santé 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Retinal detachment (RD), including both exudative types often associated with systemic diseases that might be receiving antibiotics for related conditions as well as rhegmatogenous which require prompt surgical intervention to reduce the chance of irreversible severe vision loss, has an annual incidence rate of 1 per 10,000 in the general population. Rhegmatogenous is the most common type. Fluoroquinolones are one of the most commonly prescribed classes of antibiotics. Thanks to their broad-spectrum antibacterial coverage, they are effective in the treatment of a wide variety of community-acquired infections.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Several studies have suggested that oral fluoroquinolone use increased the risk of Retinal detachment, however this association remains controversial. We conducted a nationwide self-matched design study to overcome limitations of previous studies. Our finding of a significant increased risk of  Retinal detachment, including both rhegmatogenous and exudative types, following use of oral fluoroquinolone strongly supports the existence of this association.

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Study Finds No Link To Arrhythmias From Oral Fluoroquinolones Antibiotics

MedicalResearch.com Interview with:
Malin Inghammar, MD, PhD
Department of Infectious Diseases
Skåne University Hospital, Lund
Sweden 

MedicalResearch.com: What is the background for this study?

Dr. Inghammar: Fluoroquinolones are a class of antibiotics with a widespread use in the treatment of common infections. Agents of this drug are generally well tolerated and have few side effects but in some people fluoroquinolones can prolong the QT-interval. QT-prolongation is a sort of electrical disturbance in the heart that can, in rare instances, lead to potentially life-threatening arrhythmia. Some drugs are well known to cause QT-prolongation and to be able to trigger arrhythmia. Fluoroquinolones however, have only weak effect on the QT-time. There have been a few previous studies published reporting an increased risk. Some of these, compared fluoroquinolone treated patients with people who were not treated with antibiotics at all. In these studies, it can’t be ruled out that the infection itself, rather than the antibiotic treatment could have influenced the risk of arrhythmia. In some other previous studies, there have been indications that the patients receiving fluoroquinolones were of poorer general health than the comparison group, which could also have affected the results. Therefore it is not clear if oral fluoroquinolone treatment leads to an increased risk of serious cardiac arrhythmia in an everyday clinical situation.

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Marine Microbial Cahuitamycins as Biofilm Inhibitors For Medical Devices

MedicalResearch.com Interview with:

Ashootosh Tripathi, PhD Postdoctoral Research Fellow Life Sciences Institute I Sherman lab University of Michigan Ann Arbor, MI, USA

Dr. Ashootosh Tripathi

Ashootosh Tripathi, PhD
Postdoctoral Research Fellow
Life Sciences Institute I Sherman lab
University of Michigan
Ann Arbor, MI, USA

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Tripathi: Acinetobacter baumannii is a nosocomial opportunistic and resistant pathogen that can spread epidemically among patients causing ventilator-associated pneumonia and bacteremia. The mortality rates associated with it can be as high as 60%, representing a paradigm of pathogenesis, transmission and resistance. In addition, numerous reports have shown the startling emergence of multidrug-resistant A. baumannii in hospitals as well as the identification of pan-drug-resistant strains at some locations. Among the  various reasons for the antibiotic resistance of this pathogenic microbe, perhaps the most significant is mediated by its tendency to form biofilms (a highly structured extracellular polymeric matrix), which provide the microbe with the alarming ability to colonize medical devices. Interestingly, despite the well-understood role of bacterial biofilm behind aggravating antimicrobial resistance, there are currently no drugs specifically targeting biofilms in clinical trials to date. The study sought to solve this problem through the development of a biofilm inhibitor as a precision medicine, directed towards vulnerable patients, to avoid potential life-threatening infections.

A crystal-violet based high throughput in vitro screen was developed to identify inhibitors of A. baumannii biofilms against our natural products extract (NPE) library. The vast NPE library of ~42,000 extracts has been under constant development in Prof David H. Sherman laboratory at University of Michigan, Ann Arbor, for over the past decade, from a relatively underexplored marine microbiome collected from different part of world viz., Costa Rica, Panama, Papua New Guinea, etc., and is available for any research group with a robust high-throughput screening (HTS) assay (http://www.lsi.umich.edu/centers/center-for-chemical-genomics). The HTS assay that was queried against a library of 9,831 NPEs aimed to identify extracts inhibiting biofilm formation as a primary screening. Further secondary  screening and   activity  threshold optimization revealed the extract from Streptomyces gandocaensis (collected from Costa Rica) to be of particular interest due to its ability to inhibit biofilm formation and had a limited effect on A. baumannii growth. Activity based chromatographic separation and analysis of extracts derived from S. gandocaensis resulted in the discovery of three peptidic metabolites (cahuitamycins A–C),   with cahuitamycin  C  being   the   most effective biofilm inhibitor (IC50 =14.5 µM)   with  negligible A.  baumannii growth inhibition (an important trait for ideal biofilm inhibitor). Following up on the exciting discovery, we also completely characterized the biosynthetic machinery involved in making the active molecules by S. gandocaensis, using sophisticated bioinformatics and molecular biology techniques. The knock out analysis revealed that the biosynthesis of cahuitamycin C proceeds via a convergent biosynthetic pathway, with one of the steps apparently being catalyzed by an unlinked gene encoding a 6-methylsalicylate synthase. Efforts to assess starter unit diversification through selective mutasynthesis led to production of unnatural analogues cahuitamycins D and E with increased potency (IC50=8.4 and 10.5 µM) against A. baumannii biofilm.

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Feeding Tubes Linked To Resistant Organisms In Nursing Home Patients

MedicalResearch.com Interview with:

Leonard Mermel, DO, ScM, AM (Hon), FSHEA, FIDSA, FACP Professor of Medicine, Warren Alpert Medical School of Brown University Medical Director, Dept. of Epidemiology & Infection Control, Rhode Island Hospital

Dr. Leonard Mermel

Leonard Mermel, DO, ScM, AM (Hon), FSHEA, FIDSA, FACP 
Professor of Medicine, Warren Alpert Medical School of Brown University
Medical Director, Dept. of Epidemiology & Infection Control, Rhode Island Hospital
Adjunct Clinical Professor, University of Rhode Island College of Pharmacy 

Medical Research: What is the background for this study? What are the main findings?

Dr. Mermel:  There is increasing concern in the US and abroad regarding multi-drug resistant organisms (MDROs), particularly bacteria resistant to carbapenem antibiotics.  Concern has been raised about MDRO colonization in high-risk populations, such as nursing home patients and transmission between nursing home and acute care hospitals.  Little data exists concerning the incidence of GI tract colonization of such pathogens in nursing home patients at the time of acute care hospitalization.  We used rectal swabs on 500 hospital admissions from nursing homes to assess carriage of bacteria resistant to carbapenem antibiotics.  We found carbapenem-resistant or carbapenemase-producing gram-negative bacteria in 23 of the 500 (4.6%) hospital admissions from nursing homes, which included 7 carbapenemase-producing CRE bacteria (1.4%).  The latter bacteria produce an enzyme that breaks down the carbapenem antibiotic and the resistance genes are located on mobile genetic elements.  We also found that use of gastrostomy tubes was associated with fecal carriage of gram-negative bacteria with detectable carbapenem resistance.

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Azithromycin Shortens Asthma Symptoms in Children

Professor of Pediatrics Hans Bisgaard, MD, DMSc Copenhagen Prospective Studies on Asthma in Childhood Herlev and Gentofte Hospital, University of Copenhagen, Denmark.

Prof. Bisgaard

More on Asthma on MedicalResearch.com
MedicalResearch.com Interview with:
Hans Bisgaard, MD, DMSc
Professor of Pediatrics
The Faculty of Health Sciences
University of Copenhagen
Head of the Copenhagen Prospective Studies on Asthma in Childhood
University  of Copenhagen and Naestved Hospital

Medical Research: What is the background for this study?

Dr. Bisgaard: Childhood asthma is often preceded by recurrent asthma-like symptoms in relation to airway infections in the first years of life. Bacteria and viruses are equally associated with the risk of episodes of asthma-like symptoms in these children, suggesting antibiotics as a potential treatment for such episodes.

Medical Research: What are the main findings?

Dr. Bisgaard: Our study demonstrates a clinically significant shortening of symptom duration by 63% after intervention. The effect size increased with early initiation of treatment, showing a reduction in episode duration of 83% if treatment was initiated before day 6 of the episode. Azithromycin was effective in shortening the episodes even though no pathogenic bacteria was detected. This study is, to our knowledge, the first randomized trial of azithromycin treatment of acute episodes of asthma-like symptoms in young children with a history of recurrent episodes.

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BioPharmX Developing Topical Antibiotic Minocycline For Acne Treatment

MedicalResearch.com Interview with:
Dr. Diana Lac, PhD
Senior Scientist at BioPharmX Corporation.
Dr. Lac received her PhD in Pharmacology and Toxicology from the University of California, Davis and currently focuses on the development of topical treatments for acne.

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Lac: Acne affects almost 90% of people in western societies during their teenage years and may persist into adulthood. Currently, the oral tetracycline class of drugs dominates the acne treatment market. However, these treatments have been associated with a variety of adverse effects, such as headaches, dizziness, fatigue, nausea, photosensitivity, and severe itchiness. While a variety of acne treatments do exist, topical antibiotics particularly have had limited success due to formulation challenges. A topical minocycline formulation will provide a superior alternative for local treatment of acne, thereby limiting the amount of systemic exposure to the antibiotic and addressing the overall global antibiotic resistance problem. We believe that by directly delivering the drug to the skin we can decrease the amount of antibiotic exposure and also limit the off-target effects.

We have developed a novel, stable minocycline gel formulation allowing for efficient delivery of minocycline directly to the pilosebaceous unit in the skin where Propionibacterium acnes typically reside. In this poster presentation we have demonstrated this effectively in live rats. A dose ranging study was conducted where drug delivery and safety of our novel formulation was assessed. A number of dose formulations were tested (up to 4% minocycline formulations) and were found to be non-irritating and safe for topical use.

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Early Antibiotics May Benefit Children With History Of Severe Respiratory Illness

Leonard B. Bacharier, MD Professor of pediatrics Clinical Director, Division of Allergy, Immunology and Pulmonary Medicine St Louis School of Medicine Washington University St Louis, Missouri

Dr. Bacharier

MedicalResearch.com Interview with:
Leonard B. Bacharier, MD

Professor of pediatrics
Clinical Director, Division of Allergy, Immunology and Pulmonary Medicine
St Louis School of Medicine
Washington University
St Louis, Missouri 

Medical Research: What is the background for this study? What are the main findings?

Dr. Bacharier: Oral corticosteroids such as prednisone have become the standard of care for children whose colds tend to progress and lead to severe wheezing and difficulty breathing.

“But there are some studies that suggest these treatments don’t consistently work for young children. That’s why we want to find ways to prevent upper respiratory infections from progressing to lower respiratory tract illnesses. Once the episode gets going, standard interventions are less effective than would be desired”​​​​​​​​​​​​​​​​, reported Dr. Bacharier.

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No Link Found Between Macrolide Antibiotics and Birth Defects

Anick Bérard PhD FISPE Research chair FRQ-S on Medications and Pregnancy Director, Réseau Québécois de recherche sur le médicament (RQRM) Professor, Research Chair on Medications, Pregnancy and Lactation Faculty of Pharmacy, University of Montreal Director, Research Unit on Medications and Pregnancy Research Center CHU Ste-JustineMedicalResearch.com Interview with:
Anick Bérard PhD FISPE
Research chair FRQ-S on Medications and Pregnancy
Director, Réseau Québécois de recherche sur le médicament (RQRM)
Professor, Research Chair on Medications, Pregnancy and Lactation
Faculty of Pharmacy, University of Montreal
Director, Research Unit on Medications and Pregnancy
Research Center CHU Ste-Justine

Medical Research:  Should we have any reservations about prescribing these macrolides during pregnancy?

Dr. Bérard: With penicillin, macrolides are amongst the most used medications in the general population and in pregnancy. However, debate remained on whether it is the infections or in fact the macrolides used to treat them that put women and their unborn child at greater risk of adverse pregnancy outcomes, including birth defects.
Our study was performed within the Quebec Pregnancy Cohort, one of the largest pregnancy cohorts in the World, and did not find a statistically significant association between macrolide use (a widely used class of antibiotics) during pregnancy and the risk of malformations. When looking at specific types of macrolides, no association was found between azithromycin, clarithromycin or erythromycin use during the first trimester of pregnancy and the risk of major malformations or cardiac malformations. This is reassuring when treating infections during pregnancy.

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Earlier Isotretinoin Discussion May Decrease Long-Term Antibiotic Use For Acne

Arielle Nagler MD Instructor, Department of Ronald O. Perelman Department of Dermatology NYU Langone Medical Center

Dr. Nagler

MedicalResearch.com Interview with:
Arielle Nagler MD
Instructor, Department of Ronald O. Perelman Department of Dermatology
NYU Langone Medical Center

Medical Research: What is the background for this study of acne patient who eventually require isotretinoin?

Dr. Nagler: Isotretinoin is a highly effective medication for the treatment of severe acne. In fact, it is the only medication that has been shown to provide patients with a durable cure for acne. However, its use is limited by its known teratogenicity as well as controversies regarding its relationship with psychiatric disturbances and inflammatory bowel disease. For many patients, systemic antibiotics provide an effective treatment for inflammatory acne. However, antibiotics do not provide the long term clearance that isotretinoin provides. Moreover, antibiotics are getting increasing attention due to fears of emerging bacterial resistance. There has been a recent emphasis on limiting antibiotic use in acne. As a result, this study sought to understand antibiotic use patterns amongst patients who eventually received isotretinoin.  Continue reading

Antibiotics In Childhood Linked To Higher Teenage Body Mass

Brian S. Schwartz, MD, MS Professor of Environmental Health Sciences, Epidemiology, and Medicine Co-director, Program on Global Sustainability and Health Senior Investigator, Geisinger Center for Health Research (Danville, PA) Johns Hopkins Bloomberg School of Public Health Baltimore, Maryland 21205

Dr. Brian Schwartz

MedicalResearch.com Interview with:
Brian S. Schwartz, MD, MS

Professor of Environmental Health Sciences, Epidemiology, and Medicine
Co-director, Program on Global Sustainability and Health
Senior Investigator, Geisinger Center for Health Research (Danville, PA)
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland 21205

Medical Research: What is the background for this study? What are the main findings?

Dr. Schwartz: Sub-therapeutic doses of antibiotics (not a high enough dose to treat an infection in the animal) have been added to animal feeds for decades to promote weight gain. An increasing number of studies of therapeutic uses of antibiotics in humans have reported weight gain, mostly in young children. Using electronic health record data on over 163,000 children between 3 and 18 years of age from the Geisinger Health System, our study was the first one to study the full childhood age range among mostly healthy children; to find effects of antibiotics on weight gain at all ages; to find that the more the cumulative number of antibiotics the greater the weight gain; and that some of the effects were progressive, in that the cumulative number of antibiotics caused an increasing divergence of the body mass index trajectory over time from the trajectory in children who had not received antibiotics.

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What Explains Hospital Variation In Antibiotic Usage?

James Baggs, PhD Division of Healthcare Quality Promotion Centers for Disease Control and Prevention Atlanta, GA

Dr. James Baggs, PhD

MedicalResearch.com Interview with:
James Baggs, PhD
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention
Atlanta, GA

Medical Research: What is the background for this study?

Dr. Baggs: The National Action Plan for Combating Antibiotic Resistance Bacteria calls for annual reporting of antibiotic use in inpatient settings as well as the identification of variations at the provider or patient level that can assist in developing interventions. Antibiotic use varies among hospitals, but some portion of that variability is related to the type of patients admitted to the hospital and other hospital characteristics. We evaluated factors in a large cohort of US hospitals that may account for inter-facility variability in antibiotic use, so that we can more appropriately monitor antibiotic use in hospitals.

Medical Research: What are the main findings?

Dr. Baggs: We utilized data from the Truven Health MarketScan Hospital Drug Database (HDD), which contains detailed administrative records, including inpatient drug utilization data based on billing records, for all patients discharged from a convenience sample of over 500 US hospitals. We retrospectively estimated days of therapy (DOT)/1,000 patient days (PDs) by year from 2006-2012, and created a multivariable model that adjusts for hospital-specific location of antibiotic use (ICU vs. other), average patient age, average patient co-morbidity score, number of hospital beds, teaching status, urban or rural location, proportion of discharges with a surgical diagnosis related code, case mix index, and proportion of patient days with an infectious disease primary ICD-9-CM discharge code. We observed that DOT varied significantly between hospitals; the 10th to 90th percentile values for hospital days of therapy ranged from 546 to 998/1,000 PDs. The variables included in our model accounted for 47-53% of the inter-facility variability, depending on year. However, nearly all of this variability was explained by two predictors: proportion of PDs with an infectious disease diagnosis code and hospital location (ICU vs. other). 

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No Knee-Jerk Antibiotics Campaign Aims To Reduce Antibiotic Overusage

Barbara W. Trautner, MD, PhD Houston Veterans Affairs Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center Section of Infectious Diseases, Department of Medicine Baylor College of Medicine, Houston, TexasMedicalResearch.com Interview with:
Barbara W. Trautner, MD, PhD
Houston Veterans Affairs Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey Veterans Affairs Medical Center
Section of Infectious Diseases
Department of Medicine
Baylor College of Medicine, Houston, Texas

Medical Research: What is the background for this study? What are the main findings?

Dr. Trautner: Reducing antimicrobial overuse, or antimicrobial stewardship, is a national imperative. If we fail to optimize and limit use of these precious resources, we may lose effective antimicrobial therapy in the future. CDC estimates that more than $1 billion is spent on unnecessary antibiotics annually, and that drug-resistant pathogens cause 2 million illnesses and 23,000 deaths in the U.S. each year. The use of antibiotics to treat asymptomatic bacteriuria (ASB) is a significant contributor to antibiotic overuse in hospitalized and nursing home patients, especially among patients with urinary catheters. In catheterized patients, ASB is very often misdiagnosed and treated as catheter-associated urinary tract infection (CAUTI). Therefore, we designed the “Kicking CAUTI: The No Knee-Jerk Antibiotics Campaign intervention” to reduce overtreatment of ASB and to reduce the confusion about distinguishing CAUTI from asymptomatic bacteriuria.

This study evaluated the effectiveness of the Kicking CAUTI intervention in two VAMCs between July 2010 and June 2013. The primary outcomes were urine cultures ordered per 1,000 bed-days (inappropriate screening for ASB) and cases of ASB receiving antibiotics (overtreatment). The study included 289,754 total bed days, with 170,345 at the intervention site and 119,409 at the comparison site. Through this campaign, researchers were able to dramatically decrease the number of urine cultures ordered. At the intervention site, the total number of urine cultures ordered decreased by 71 percent over the course of the intervention. Antibiotic treatment of asymptomatic bacteriuria decreased by more than 75 percent during the study. No significant changes occurred at the comparison site over the same time period. Failure to treat catheter-associated urinary tract infection when indicated did not increase at either site. Continue reading

The Infectious Diseases Society of America Comments on the 21st Century Cures Bill Including Antibiotic Development

Ms. Amanda Jezek Director of Government Relations Infectious Diseases Society Of AmericaMedicalResearch.com Interview with:
Ms. Amanda Jezek
Director of Government Relations
Infectious Diseases Society Of America

Editor’s Note: The Infectious Diseases Society of America Comments on the 21st Century Cures bill,  a bill desigend  “to help modernize and personalize health care, encourage greater innovation, support research” including important issues surrounding antimicrobial resistance and antibiotic development.

Ms. Amanda Jezek has been Director of Government Relations at Infectious Diseases Society of America (ISDA) since July 2011. Ms. Jezek is “is responsible for policy development and advocacy on IDSA priority issues including antimicrobial resistance, antimicrobial and diagnositcs development, preparedness and federal funding’.

MedicalResearch: What are the main objectives of the 21st Century Cures bill? 

Ms. Jezek: This question goes far beyond IDSA’s work on the bill, so I would not be comfortable being quoted on this. The Energy and Commerce Committee’s website has more information.  Very generally, the bill seeks to advance the research and development of new cures for patients with a wide variety of diseases and conditions.

MedicalResearch: What health care needs and problems does it address? 

Ms. Jezek: I can only answer from IDSA’s perspective, keeping in mind that many sections of this bill go well beyond the field of ID.  IDSA is very pleased that the bill prioritizes the research and development of some of the most urgently needed new antibiotics to treat serious or life threatening infections with few or no current treatment options.  IDSA is also very pleased that the bill takes important steps to increase funding for NIH, which is urgently needed to ensure adequate investment in biomedical research and support for young people entering or thinking of pursuing research careers.

MedicalResearch: Does the proposed legislation address hospital-based infections, antibiotic resistance, pandemic detection and management, vaccine issues such as mandatory vaccination of school age children, or antibiotics in food sources? 

Ms. Jezek: The bill’s focus is really biomedical research and development and as these issues fall more into the public health sphere, they are not the specific focus of the bill.  However, the provisions aimed at antibiotic R&D also include language aimed at making sure the antibiotics are used appropriately and that their use is monitored, both of which are critical for addressing antibiotic resistance.

MedicalResearch: Does the legislation enable simplified access to clinical medical research trials or expedited review of new pharmaceuticals and medications

Ms. Jezek: I’m only answering from IDSA’s perspective, understanding that we are not involved in every provision in the bill and other provisions may address these issues.  One of the antibiotics provisions, which IDSA has been championing, would allow antibiotics to treat serious or life threatening infections with few or no current treatment options to be studied in smaller, more rapid clinical trials and approved only for the limited population of patients who need them.  This approach is needed because some of the most deadly, difficult to treat infections currently occur in small numbers of critically ill patients who are difficult to enroll in clinical trials, making it very difficult and sometimes impossible to populate traditional, large clinical trials.

MedicalResearch: How will patients benefit from bill?

Ms. Jezek: The bill will help enable the development of new safe and effective antibiotics to treat infections that could otherwise be lethal.  Such antibiotics could literally mean the difference between life or death for patients with these infections.

MedicalResearch: What should health care providers be aware of if the legislation passes?

Ms. Jezek: I think all of the components that IDSA is pursuing—specifically regarding antibiotic development and NIH funding—would be of great interest to providers given their potential impact on new treatment options for patients.

MedicalResearch: Is funding for implementation of the bill included in the legislation?

Ms. Jezek: As I understand it, the Committee is still working on some of this, so I can only provide a partial answer.  For the NIH funding-the bill would authorize new money for NIH for the next 3 years, but the Appropriations Committee in Congress would still need to actually appropriate that money.  However, the NIH Innovation Fund in the bill would provide mandatory funding for NIH for the next 5 years, and this would not have to be approved by the Appropriations Committee.  Some parts of the bill (such as the limited population antibiotic development provision discussed above) are not expected to require additional funding, as it is merely addressing a regulatory barrier.  Lastly, some funding items are still being worked out.

Citation:

(See a two-page Fact Sheet of H.R. 6 HERE. )

 

Ms. Amanda Jezek, Director of Government Relations, & Infectious Diseases Society Of America (2015). The Infectious Diseases Society of America Comments on the 21st Century Cures Bill Including Antibiotic Development 

Early Life Exposure To Antibiotics May Impact Adult Health

MedicalResearch.com Interview with:
Ms. Pajau Vangay

Graduate Research Fellow
Biomedical Informatics and Computational Biology
Vice President of Grants, Council of Graduate Students
University of Minnesota

Medical Research: What is the background for this study? What are the main findings?

Response: Previous studies showed links between antibiotic use and unbalanced gut bacteria, and others showed links between unbalanced gut bacteria and adult disease. Over the past year we synthesized hundreds of studies and found evidence of strong correlations between antibiotic use, changes in gut bacteria, and disease in adulthood.

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NEJM Research Discusses Right Antibiotic Strategy For Community-Acquired Pneumonia in Adults

Henri van Werkhoven PhD student | Julius Center for Health Sciences and Primary Care University Medical Center Utrecht, Utrecht, The NetherlandsMedicalResearch.com Interview with:
Henri van Werkhoven
PhD student and

Douwe-PostmaDouwe Postma
PhD student
Julius Center for Health Sciences and Primary Care
University Medical Center Utrecht, Utrecht, The Netherlands

Medical Research: What is the background for this study? What are the main findings?

Response: Community-acquired pneumonia is an important cause of hospitalization and death worldwide. Recommendations for antibiotic treatment in patients hospitalized to a non-ICU ward vary widely between guidelines, because the optimal antibiotic strategy is unknown. Interpretation of the available evidence from clinical studies is complicated by the heterogeneity in designs and findings. In our study, we hypothesized that the most conservative strategy, beta-lactam monotherapy, would be non-inferior to strategies with a broader range of antibiotic coverage. The latter strategies are potentially related to increased antibiotic resistance.

For this purpose, we randomized hospitals to follow three different strategies of preferred antibiotic treatment in consecutive periods of four months. Physicians were allowed to deviate from the preferred antibiotic treatment for medical reasons. We found that a strategy with beta-lactam monotherapy (e.g. amoxicillin) as the preferred treatment was non-inferior to the strategies with beta-lactam/macrolide combination therapy or fluoroquinolone monotherapy for 30 and 90-day all-cause mortality. Also there was no difference in length of hospitalization and rate of complications.

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Health Care Waste in Landfills May Promote Antibiotic Resistance

Dr. Thiago César Nascimento Assistant Professor, Department of Basic Nursing Laboratory of Bacterial Physiology and Molecular Genetics Institute of Biological Sciences Federal University of Juiz de Fora, BrazilMedicalResearch.com Interview with:
Dr. Thiago César Nascimento
Assistant Professor, Department of Basic Nursing
Laboratory of Bacterial Physiology and Molecular Genetics
Institute of Biological Sciences
Federal University of Juiz de Fora, Brazil

Medical Research: What is the background for this study? What are the main findings?

Response: Preliminarily, we observed a high incidence of coagulase-negative  Staphylococcus  strains (CoNS) recovered from the leachate of the health care waste in an untreated sanitary landfill. As Staphylococcus sp. especially oxacillin or methicillin-resistant CoNS remains as important putative pathogenic bacteria regarding human and other animals, in this study we investigated the antimicrobial susceptibility patterns and the occurrence of the  mecA  gene. In conclusion, our results raise issues related to the viability of putative pathogenic bacteria resistant to important antimicrobial drugs carrying important resistance markers in untreated healthcare waste in sanitary landfills.These risks regarding the potential spread of leachate from sanitary landfills due to human and animal activities, or even due to weather phenomena, such as torrential rains and floods, should be considered. Our results address a phenomenon related to the incorrect healthcare waste management in Brazil and in other geographical regions. Taking into account environmental health, more conscientious  policies should be considered by authorities to avoid the disposal of healthcare waste without any further treatment.

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Preventive Antibiotics Did Not Improve Stroke Outcomes But Reduced Infections

MedicalResearch.com Interview with:
Prof. dr. Diederik van de Beek
Department of Neurology,
Academic Medical Center, University of Amsterdam
The Netherlands

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. van de Beek: In adults with acute stroke, infections occur commonly and are associated with an unfavourable functional outcome. In the Preventive Antibiotics in Stroke Study (PASS) we aimed to establish whether or not preventive antimicrobial therapy with a third-generation cephalosporin, ceftriaxone, improves functional outcome in patients with acute stroke. PASS is an investigator-initiated, randomised, open-label, masked-endpoint trial that was undertaken between 2010 and 2014 in 30 Dutch centres and enrolled 2550 patients with ischaemic or haemorrhagic stroke. Randomly assigned in a 1:1 ratio to either preventive antibiotic therapy or a control group, all patients received standard stroke unit care. Starting within 24 h after stroke onset, patients in the preventive antibiotic group were given additional treatment with ceftriaxone administered intravenously at a dose of 2 g every 24 h for 4 days. The main findings were that preventive ceftriaxone did not improve 3-month functional outcome on the modified Rankin Scale (adjusted common odds ratio 0·95 [95% CI 0·82–1·09]); however, clinically diagnosed post-stroke infections were significantly reduced (adjusted odds ratio 0·55 [0·44–0·70]). Preventive antibiotic therapy with ceftriaxone is a safe treatment. Continue reading

Cholera Bacteria Kills Neighbors To Acquire Antibiotic Resistance Genes

Melanie Blokesch PhD Assistant Professor (tenure-track) Laboratory of Molecular Microbiology Global Health Institute, School of Life Sciences Swiss Federal Institute of Technology Lausanne (EPFL) Lausanne SwitzerlandMedicalResearch.com Interview with:
Melanie Blokesch PhD

Assistant Professor (tenure-track)
Laboratory of Molecular Microbiology
Global Health Institute, School of Life Sciences
Swiss Federal Institute of Technology Lausanne (EPFL)
Lausanne Switzerland

Medical Research: What is the background for this study? What are the main findings?

Dr. Blokesch: We have been studying the cholera-causing bacterium Vibrio cholerae for many years in my laboratory. Our main focus has always been on elucidating how this pathogen acquires new genetic material that allows it to evolve. This is often accomplished through a mechanism known as horizontal gene transfer (HGT). There are three main modes of horizontal gene transfer in bacteria and the one we are primarily interested in is called natural competence for transformation. When the bacterium enters the state of natural competence it can take up free genetic material from its surrounding and in case it recombines this new material into its own genome the bacterium is considered to be naturally transformed. Notably, natural competence/transformation was first described in 1928 by Fred Griffith, who showed that transformation can render harmless bacteria pathogenic. These early experiments can be considered a milestone in molecular biology as it later led to the discovery of DNA as the carrier of genetic information.

Medical Research: What are the main findings?

Dr. Blokesch: The main finding of our study is that the pathogen V. cholerae does not solely rely on free DNA floating around but that it actively kills neighbouring bacteria followed by the uptake of their DNA. Indeed, we were able to show that the two processes – killing of other bacteria and DNA uptake – are co-regulated by the same proteins within the bacterial cell. We also used imaging techniques to visualize the killing of other bacteria by V. cholerae, followed by the release of their genetic material, which the predator then pulled into its own cell. We further quantified these HGT events by following the transfer of an antibiotic resistance gene from the killed bacterium to the predatory V. cholerae cell. Notably, the spread of antibiotic resistances is a major health concern and HGT is a major driver of it.

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Which Antibiotics Have Increased Risk of Cardiac Arrhythmias?

Jiun-Ling Wang MD Associated professor at Medical school in I-Shou University infectious disease doctor at E-DA Hospital, Kaohsiung , TaiwanMedicalResearch.com Interview with:
Jiun-Ling Wang MD

Associated professor at Medical school in I-Shou University
infectious disease doctor at E-DA Hospital, Kaohsiung , Taiwan

Medical Research: What is the background for this study? What are the main findings?

Dr. Wang: Some study showed increase cardiovascular death in azithromycin user. But there lacks of data in other antibiotics in the treatment for respiratory tract infections.

So we used the Taiwan National Health Insurance Database to perform a nationwide, population-based study comparing the risks of ventricular arrhythmia and cardiovascular death among patients using these antibiotics. And we find azithromycin, and moxifloxacin were associated with higher risk of ventricular arrhythmia cardiovascular death than amoxicillin/clavunate.

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UK Drop in Antibiotic Prophylaxis Linked To Increased Number of Heart Infections

MedicalResearch.com Interview with:
Dr. Martin Thornhill PhD

Department of Cardiology, Taunton and Somerset NHS Trust
Taunton, Somerset, UK

Medical Research: What is the background for this study? What are the main findings?

Dr. Thornhill: In 2008 NICE introduced controversial new guidance recommending that antibiotic prophylaxis to prevent infective endocarditis should no longer be used. It was a rational decision, given the evidence for the effectiveness of antibiotic prophylaxis and potential concerns about costs, the development of antibiotic resistance and possible side effects from antibiotics, but it went against other guidelines from around the world that existed at the time.

The main findings are that in England:

  1. There has been a large and significant decline in the use of antibiotic prophylaxis.
  2. There has been a significant increase in the number of cases of infective endocarditis, above the baseline trend, using hospital coding data, corrected for changes in the size of the English population.

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Antibiotics May Increase Risk of Juvenile Arthritis

MedicalResearch.com Interview with:
Dr. Daniel B Horton, MD
Division of Pediatric Rheumatology
Department of Pediatrics
Nemours Dupont Pediatrics Wilmington, Delaware

Medical Research: What is the background for this study? What are the main findings?

Dr. Horton: The reasons why children develop juvenile arthritis (JIA) are unclear. To date, genetic variation accounts for only a minority of disease incidence, and no environmental factor has consistently been associated with juvenile arthritis. There is growing understanding about the role of microbiome disturbance in the development of multiple diseases, including obesity, inflammatory bowel disease, and rheumatoid arthritis. Exposure to antibiotics, a known disruptor of the human microbiome, has been linked to pediatric conditions including inflammatory bowel disease, asthma, and obesity.

We showed that antibiotic prescriptions are associated with the development of new JIA diagnosis in a large general pediatric population, after accounting for history of infection and other relevant factors. This association is stronger for those who have received multiple courses of antibiotics and appears specific for antibacterial antibiotics, such as penicillins and sulfa drugs.
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“Time-Outs” To Assess Antibiotics Reduce Both Antibiotics Use and Costs

MedicalResearch.com Interview with:
Todd Lee MD MPH FRCPC
Consultant in Internal Medicine and Infectious Diseases
Assistant Professor of Medicine, McGill University
Director, General Internal Medicine Consultation Service,
Chief of Service, 6 Medical Clinical Teaching Unit,
McGill University Health Centre

Medical Research: What is the background for this study? What are the main findings?

Dr. Lee: Antibiotics are often misused and overused in hospitalized patients leading to harms in terms of side effects, infections due to Clostridium dificile, the development of antibiotic resistance, and increased health care costs.  Antimicrobial stewardship is a set of processes which are employed to improve antibiotic use.  Through various techniques, stewardship seeks to ensure the patient receives the right drug, at the right dose, by the right route, for the right duration of therapy.  Sometimes this means that no antibiotics should be given.

In implementing antimicrobial stewardship programs, some of the major challenges larger health care centers face include limitations in the availability of trained human resources to perform stewardship interventions and the costs of purchasing or developing information technology solutions.

Faced with these same challenges, we hypothesized that for one major area of our hospital, our medical clinical teaching units, we could use our existing resources, namely resident and attending physicians, to perform “antimicrobial self-stewardship”.  This concept tied the CDCs concept of antibiotic “time outs” (periodic reassessments of antibiotics) to a twice weekly audit using a locally developed checklist.  These audits were performed by our senior resident physicians in the context of providing their routine clinical care.  We also provided local antibiotic guidelines and regular educational sessions once a rotation.

We demonstrated a significant reduction in antibiotic costs as well as improvement in two of the four major classes of antibiotics we targeted as high priority.  We estimated we saved between $140 and $640 in antibiotic expenses per hour of clinician time invested.

Anecdotally, trainees felt the process to be highly valuable and believed they better understood the antibiotic use for their patients. Continue reading

Bacterial Biofilms Make Joint Infections Resistant to Antibiotics

MedicalResearch.com Interview with:
Sana Dastgheyb
National Institute of Allergy and Infectious Diseases, The National Institutes of Health, Bethesda, MDDepartment of Orthopedic Surgery,
Thomas Jefferson University, Philadelphia, PA and

Dr. Noreen Hickok
Department of Orthopedic Surgery
Thomas Jefferson University, Philadelphia, PA

Medical Research: What are the main findings of the study?

Response: Physicians have long been resigned to the fact that staphylococcal joint infections are among the most challenging to treat. Our study points towards a definitive mechanism whereby bacteria become insensitive to antibiotics in the human joint environment. We added MRSA to synovial fluid and observed dense, biofilm-like aggregates, as well as a relative insensitivity to antibiotics as compared to ideal medium. Our findings suggest that serum/extracellular matrix proteins within synovial fluid contribute greatly to staphylococcal antibiotic insensitivity in synovial fluid. Furthermore, pre-treatment of synovial fluid with the enzyme plasmin, which degrades extracellular matrix proteins, significantly inhibits aggregate formation, and restores normal antibiotic sensitivity to MRSA.

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Community Acquired Pneumonia May Require Two Antibiotics

MedicalResearch.com Interview with:
Dr. Nicolas Garin MD
Division of General Internal Medicine, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland
Division of Internal Medicine, Hôpital Riviera-Chablais, Monthey, Switzerland

Medical Research: What are the main findings of the study?

Dr. Garin: Empiric treatment with a betalactam drug (monotherapy) was not equivalent to the combination of a betalactam and a macrolide in patients hospitalized for moderate severity pneumonia (proportion of patients not having reached clinical stability at day 7 was 41.2 % in the monotherapy vs. 33.6 % in the combination therapy arm, between arm difference 7.6 %). This occurred despite systematic search for Legionella infection in the monotherapy arm. There was no difference in early or late mortality, but patients in the monotherapy arm were more frequently readmitted. Patients with higher severity of disease (in PSI category IV, or with a CURB-65 score higher than 1) seemed to benefit from combination therapy (HR 0.81 for the primary outcome of clinical instability at day 7), although it was statistically not significant. There was no difference in the primary outcome for patients in PSI category I to III.

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Adverse Reactions to Cephalosporin Antibiotics Reviewed

Eric Macy, MS, MS Allergy & Immunology Kaiser Permanente Medical Group-AllergyMedicalResearch.com Interview with:
Eric Macy, MS, MS
Allergy & Immunology
Kaiser Permanente Medical Group-Allergy

 

Medical Research: What are the main findings of the study?

Dr. Macy:

  • Cephalosporins are currently widely and relatively safely used in individuals with a history of a penicillin “allergy” in their medical record.
  • Cephalosporin associated anaphylaxis is very rare, even in individuals with a history of penicillin “allergy”.
  • Cephalosporin associated serious cutaneous adverse reactions are extremely rare.
  • Cephalosporin associated Clostridium difficile and serious nephropathy are relatively common.
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New Ionic Liquids May Disrupt Pathogenic Biofilms, Enhance Antibiotic Delivery

MedicalResearch.com Interview with:
David T. Fox, Ph.D. Scientist 3 Los Alamos National Laboratory andDavid T. Fox, Ph.D.
Scientist 3
Los Alamos National Laboratory and
Prof. Samir Mitragotri Center for Bioengineering and Department of Chemical Engineering University of California, Santa Barbara, CA 93106Prof. Samir Mitragotri
Center for Bioengineering and Department of Chemical Engineering
University of California, Santa Barbara, CA 93106


Medical Research: What are the main findings of this study?

Answer: Our research team identified a molten salt, choline-geranate, that possessed multiple beneficial biological traits. Specifically, when mixed in a 1:2 ratio (choline:geranate) this solvent is able to effectively disrupt and neutralize 72-hour biofilms formed by both Pseudomonas aeruginosa and Salmonella enterica. Further, our studies demonstrated the same solvent exhibited minimal cytotoxicity effects to normal human bronchial epithelial (NHBE) cells and was able to deliver an antibiotic, cefadroxil, through the stratum corneum into the epidermis and dermis. Most importantly, the research culminated in demonstrating the molten salt was able to neutralize ~95% of the bacteria found within a 24-hour P. aeruginosa biofilm when grown on a skin wound model (MatTek)  and ~98% of the bacteria when formulated with the antibiotic, ceftazidime. When the biofilm was treated with only antibiotic in a saline solution, less than 20% of the bacteria were neutralized.
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Impetigo Effectively Treated With Short Course of Antibiotics

Dr. Asha Bowen FRACP Menzies School of Health Research Charles Darwin University Darwin, NT, AustraliaMedicalResearch.com Interview with:
Dr. Asha Bowen FRACP
Menzies School of Health Research
Charles Darwin University
Darwin, NT, Australia

Medical Research: What are the main findings of the study?

Dr. Bowen: The Skin Sore Trial found that short courses (3 days of twice daily dosing or 5 days of once daily dosing) of oral co-trimoxazole worked just as well for treating impetigo in remote Indigenous Australian children as the standard treatment with an intramuscular injection of penicillin (BPG). Despite many randomised controlled trials (RCTs) on this common infection of childhood, few have been conducted where impetigo is severe and endemic and with over 100 million children affected at any one time, ongoing research is needed. This is only the second RCT to study impetigo in children where the problem is endemic and often severe. In our study, 70% of children had severe impetigo with a median of 3 body regions affected. BPG injections are painful and we knew from previous studies that not many children were receiving them. Our study confirmed that 30% of children had injection site pain 48 hours after receipt of the injection and 5 children ran away when they found out that they were randomised to the injection arm of the study.
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