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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