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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