Author Interviews, Biomarkers, Infections, NEJM, University of Pittsburgh / 19.07.2018

MedicalResearch.com Interview with: David T. Huang, MD, MPH Associate Professor, Critical Care Medicine, Emergency Medicine, Clinical and Translational Science Director, MACRO (Multidisciplinary Acute Care Research Organization) Director, CRISMA Administrative Core (Clinical Research, Investigation, and Systems Modeling of Acute illness) University of Pittsburgh MedicalResearch.com: What is the background for this study? Response: The overuse of antibiotics has become a serious threat to global public health, causing antibiotic resistance and increasing health care costs. Physicians have long known that antibiotics are usually unnecessary for acute bronchitis and for some other cases of lower respiratory tract infections, and that antibiotics treat only bacterial infections, not viral. But in daily practice, many physicians often prescribe them. Previous research had reported that using a biomarker blood test and following an antibiotic guideline tied to the test results could reduce antibiotic use in lower respiratory tract infections. In February 2017, the U.S. Food and Drug Administration approved the biomarker test that measures procalcitonin – a peptide that typically increases in bacterial infections, but not viral. We conducted the Procalcitonin Antibiotic Consensus Trial (ProACT) trial to evaluate whether a procalcitonin antibiotic prescribing guideline, implemented for the treatment of suspected lower respiratory tract infection with reproducible strategies, would result in less exposure to antibiotics than usual care, without a significantly higher rate of adverse events. The ProACT trial involved 14 predominately urban academic hospitals. We enrolled 1,656 adult patients who presented to the hospital emergency department and were initially diagnosed with a lower respiratory tract infection. All the patients were tested for their procalcitonin levels, but the results were shared only with the physicians of the patients randomly assigned to procalcitonin-guided antibiotic prescription. (more…)
Author Interviews, Infections / 21.05.2018

MedicalResearch.com Interview with: Christopher M. Waters PhD Departments of Microbiology and Molecular Genetics BEACON Center for The Study of Evolution in Actio Michigan State University East Lansing, MI  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our research really centers on understanding and targeting bacterial biofilms. These are multicellular communities of bacteria encased in a slimy matrix that protects them from the immune system and antibiotic treatment during infections. One of the most common types of biofilm infections is in the lungs of cystic fibrosis by the bacterium Pseudomonas aeruginosa. CF patients can become chronically colonized by P. aeruginosa, and antibiotics are not able to clear these infections. Our idea was can we find other molecules that make antibiotics more effective at killing biofilms? To this end, we screened about 6,000 compounds for those that would make tobramycin more effective at killing P. aeruginosa biofilms, and one of the best hits we found was the antimicrobial triclosan that has been widely used for decades in hand sanitizers, soaps, and tooth paste. Although neither triclosan nor tobramycin can kill biofilms alone, the combination is 100X more effective against virtually every P. aeruginosa strain tested. It also worked against other bacteria that commonly infect cystic fibrosis lungs such as Staphylococcus aureus and Burkholderia cenocepacia. (more…)
Author Interviews, Infections, Pain Research, PLoS, Urinary Tract Infections / 17.05.2018

MedicalResearch.com Interview with: Ingvild Vik MD Doctoral Research Fellow Department of General Practice Institute of Health and Society - UiO University of Oslo, Norway MedicalResearch.com: What is the background for this study? Response: Uncomplicated urinary tract infection (UTI) is the most common bacterial infection in women. It is painful and troublesome, and even though it is often self-limiting most women who see a doctor will be prescribed an antibiotic, as antibiotics provide quick symptom relief.  Antibiotic resistance is a growing, serious public health problem. Antibiotic use is the main contributor to antibiotic resistance, and to stop the rapid development it is crucial that we reduce unnecessary use of antibiotics. Antibiotics can cause unpleasant and potentially severe side effects, so avoiding unnecessary use is also beneficial for the individual patient. A small German trial published in 2010 by Bleidorn et al. suggested that ibuprofen was non-inferior to the antibiotic ciprofloxacin in achieving symptomatic cure in uncomplicated UTI. This inspired us to conduct a larger trial to compare the anti-inflammatory drug ibuprofen to antibiotics in the treatment of uncomplicated UTI.  (more…)
Author Interviews, Infections / 15.05.2018

MedicalResearch.com Interview with: Dr. Tom Lodise PharmD, Professor Albany College of Health Sciences, NY  MedicalResearch.com: What is the background for this study? Response: P. aeruginosa (PSA) is intrinsically resistant to many commercially available antibiotics and also has a remarkable capacity to develop resistance to commonly used antibiotics like carbapenems, aminoglycosides, and fluoroquinolones. The terms ‘multidrug resistant’ (MDR) and ‘pan-drug resistant’ are often used to characterize the different patterns of multiple drug resistance exhibited by PSA. Patients with MDR-PSA infections are at an increased risk for delayed receipt of appropriate antimicrobial therapy and ample studies indicated that receipt of delayed appropriate therapy results in substantial increases in morbidity, mortality, and healthcare resource utilization. Although risk factors for these types of infections have previously been identified in the literature, this study takes identification of risk factors further, and develops two clinical risk scores to estimate the probabilities of carbapenem and extensively beta-lactam non-susceptibility among hospitalized, adult patients with PSA infections based on covariates available on clinical presentation. We focused on these two PSA non-susceptible phenotypes as they represent infections at high risk of delayed appropriate therapy due to resistance against the current commonly prescribed empiric anti-pseudomonal antibiotics. (more…)
Author Interviews, Kidney Stones, Microbiome, Urology / 15.05.2018

MedicalResearch.com Interview with: Gregory Tasian MD, MSc, MSCE Assistant Professor of Urology and Epidemiology University of Pennsylvania Perelman School of Medicine Division of Urology and Center for Pediatric Clinical Effectiveness The Children’s Hospital of Philadelphia MedicalResearch.com: What is the background for this study? What are the main findings? Response:  We found that five classes of commonly prescribed antibiotics were associated with an increased risk of kidney stones. These classes were sulfa drugs (e.g. Bactrim), fluoroquinolones (e.g. Cipro), cephalosporins (e.g. cephalexin), nitrofurantoin, and broad-spectrum penicillins (e.g. augmentin).  For those five classes of antibiotics, the greatest risk was found among younger patients. However, the increased risk was still significant across all ages, including for older adults with the exception of broad-spectrum penicillins, which were not associated with an increased risk of kidney stones among patients >75 years of age. We conducted this study because: 1) Prior investigations have demonstrated that changes in the gut microbiome were associated with kidney stones, 2) Antibiotics are prescribed frequently, and 3) The number of people affected by kidney stone disease has increased 70% over the last 30 years and the greatest increases have been found among children and adolescents. Our results were consistent with these previous studies, so we were not surprised with the findings although we did not know which specific classes of antibiotics would be associated with an increased risk of stones and which ones would not. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Infections, Merck / 10.05.2018

MedicalResearch.com Interview with: Becky Jayakumar, PharmD College of Pharmacy Assistant Professor of Pharmacy Practice Roseman University of Health Sciences MedicalResearch.com: What is the background for this study? What are the main findings? Response: Bacteremia (bloodstream infections) due to Gram-negative (GN) bacteria are a frequent cause of severe sepsis and pose serious therapeutic challenges due to multidrug-resistance (MDR). Ceftolozane/tazobactam (C/T) is a novel antipseudomonal cephalosporin combined with an established β-lactamase inhibitor. This retrospective, observational study evaluated the clinical outcomes of C/T real-world use in severely ill patients. Twenty-two patients with sepsis and/or bacteremia were included; 95% of whom had Pseudomonas aeruginosa that was resistant to almost all antibacterials with the exception of colistin. C/T successfully treated the majority of these complicated patients. In this real-world study, 77% of patients had a clinical response with C/T and 75% had a microbiological response. Clinical success rates were high and mortality rates were similar to other studies in this severely ill population. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Infections, Merck / 10.05.2018

MedicalResearch.com Interview with: Amanda Paschke, MD, MSCE Senior principal scientist Infectious disease clinical research Merck Research Laboratories MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study sought to evaluate a new beta-lactam/beta-lactamase inhibitor antibacterial combination, imipenem/relebactam (IMI/REL), compared with colistin plus imipenem for the treatment of infections caused by resistant Gram-negative bacteria. Patients enrolled in the trial had hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP), complicated intra-abdominal infections (cIAI), or complicated urinary tract infections (cUTI) caused by pathogens that were non susceptible to imipenem, a carbapenem antibacterial. In this study, the primary outcome was a favorable overall response to treatment, which was comparable between the IMI/REL vs colistin + IMI arms. Colistin (often combined with a carbapenem) is currently among the standard of care treatment regimens for MDR infections.  A key secondary endpoint of the study was safety.  IMI/REL was well tolerated; among all treated patients, drug-related adverse events (AEs) occurred in 16.1% of IMI/REL and 31.3% of colistin + IMI patients with treatment-emergent nephrotoxicity observed in 10% (3/29 patients) and 56% (9/16 patients), respectively (p=0.002). Results of the trial support the use of imipenem-relebactam (IMI/REL) as an efficacious and well-tolerated treatment option for carbapenem-resistant infections.  (more…)
Author Interviews, CDC, Infections, JAMA / 26.03.2018

MedicalResearch.com Interview with: Dr. Katherine Fleming-Dutra, MD, senior author Deputy Director Office of Antibiotic Stewardship CDC MedicalResearch.com: What is the background for this study? What are the main findings? Response: As noted in a previous study, antibiotics are prescribed more for sinus infections than any other illness in the United States. We found that almost 70% of antibiotic prescriptions were for 10 days or longer, whereas 5-7 days is recommended for most patients when antibiotics are needed. In addition, more than 20% of antibiotic prescriptions for sinus infections were for 5 days of azithromycin, even though guidelines recommend against prescribing azithromycin for sinus infections. (more…)
Author Interviews, JAMA, University of Michigan, Urinary Tract Infections / 12.03.2018

MedicalResearch.com Interview with: Keith SKayeMD, MPH Professor of Medicine, Division of Infectious Diseases University of Michigan Medical School Ann Arbor MI  MedicalResearch.com: What is the background for this study? Response: Complicated complicated urinary tract infections (cUTI), including acute pyelonephritis, are a major cause of hospital admissions, and are associated with significant morbidity and mortality and can be difficult to treat. While the most common pathogen is Escherichia coli, the more problematic pathogens are multidrug-resistant (MDR) gram-negative organisms including other Enterobacteriaceae species. The prevalence of cUTI due to MDR gram-negative bacteria has risen. In some instances, MDR gram-negative bacteria isolated from the urinary tract can cause bacteremia. Vabomere was approved by the U.S. Food and Drug Administration (FDA) in August 2017 for the treatment of adult patients with cUTI, including pyelonephritis, caused by designated susceptible Enterobacteriaceae: Escherichia coli, Klebsiella pneumoniae and Enterobacter cloacae species complex.   Vabomere is a fixed-dose (2g/2g) combination product of a carbapenem and a β-lactamase inhibitor with potent in vitro activity against Klebsiella pneumoniae carbapenemase (KPC)-producing carbapenem-resistant Enterobacteriaceae (CRE), an important MDR organism associated with serious infections. The Targeting Antibiotic Non-susceptible Gram-negative Organisms (TANGO I) trial was the pivotal Phase 3 study that compared the efficacy and safety of Vabomere to piperacillin-tazobactam in the treatment of patients with cUTI and acute pyelonephritis. (more…)
Author Interviews, Infections / 12.03.2018

MedicalResearch.com Interview with: Michael Durkin, MD MPH Washington University School of Medicine St. Louis MedicalResearch.com: What is the background for this study? What are the main findings? Response: The aim of this study was to evaluate overall national outpatient antibiotic prescribing trends using a pharmacy benefits manager (Express Scripts). We wanted to evaluate if antibiotic prescribing had decreased as a result of increase physician awareness of antibiotic prescribing. Specifically, the ABIM choosing wisely campaign overlapped with our study period. We did not see any significant reductions in antibiotic prescribing during the 3-year study period. This is a little disappointing given that the CDC estimates that 30% of outpatient antibiotic prescriptions are inappropriate. We also saw some seasonal variation in antibiotic prescribing. This isn’t particularly novel. But it is important to note, as some of these prescriptions represent providers writing antibiotics for likely viral conditions. (more…)
Author Interviews, Education, Infections, Pediatrics / 23.02.2018

MedicalResearch.com Interview with: Ole Köhler-Forsberg, PhD Student Department of Clinical Medicine - Psychosis Research Unit Aarhus University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prior studies have demonstrated that serious illnesses, for example severe infections such as measles, rubella or meningitis, which we vaccinate against, affect the brain and thereby the child's ability to learn. From this we know that illnesses and in particular infections to some degree have an influence on our brains. In this study, we decided to look at how children perform following the less severe infections that many of them frequently experience during their childhood. After all, this is the largest group of children, but this has not been studied previously in such a large population. Basically, we found that among 598,553 Danes born 1987-1997, the less severe infections treated with anti-infective agents during childhood did not affect the child´s ability to perform well in school, nonetheless whether 5, 10 or 15 prescriptions had been prescribed. On the other hand, we found that children who had been admitted to hospital as a result of severe infections had a lower chance of completing 9th grade. The decisive factor is therefore the severity of the disease, but not necessarily the number of sick days.   (more…)
Author Interviews, Infections, JAMA, Surgical Research / 30.01.2018

MedicalResearch.com Interview with: Marc D. Basson, MD, PhD, MBA Professor of Surgery, Pathology, and Biomedical Science Senior Associate Dean for Medicine and Research University of North Dakota School of Medicine & Health Sciences Grand Forks, ND 58202    MedicalResearch.com: What is the background for this study? What are the main findings? Response: There are now several studies that describe the use of antibiotics without surgery to manage acute uncomplicated appendicitis. This entails a prolonged treatment course and has a substantial rate of failure and recurrence, but in patients in whom it succeeds surgery can be avoided. Many surgeons resist offering this choice because they perceive it as substandard compared to surgery, which is rapid, and when it goes well (as it usually does) has no failure or recurrence rate. Instead of debating the statistics, we decided to ask people what they would prefer if they had appendicitis and why. We found that about nine tenths of people would choose surgery, but about one tenth would choose antibiotics, with some subtle distinctions depending on the characteristics of the people we asked.  (For instance, surgeons, doctors in general, and people who knew someone who had previously had appendicitis were all a bit more likely to opt for surgery.)  Furthermore, we found that the key issue for most people was not the prolonged treatment course but the rates of failure and recurrence with antibiotics. (more…)
Author Interviews, Infections, JAMA, OBGYNE, Surgical Research, Weight Research / 20.09.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Dermatology, Infections / 22.06.2017

MedicalResearch.com Interview with: 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/  )   (more…)
Author Interviews, JAMA, Johns Hopkins, Outcomes & Safety / 14.06.2017

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. (more…)
Author Interviews, Infections, Merck / 08.06.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Infections, JAMA, UCLA / 31.05.2017

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. (more…)
Author Interviews, Dental Research, Heart Disease, Infections, Mayo Clinic / 24.05.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Infections, UCLA / 22.05.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, CMAJ, Infections, OBGYNE / 03.05.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Infections, Microbiome, OBGYNE, Pediatrics / 05.04.2017

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. (more…)
Author Interviews, Dermatology / 23.03.2017

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. (more…)
Author Interviews, C. difficile, Hospital Acquired, JAMA / 06.02.2017

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 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. (more…)
Author Interviews, Pediatrics, Weight Research / 01.02.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Kaiser Permanente, Lancet, Pediatrics, Weight Research / 29.12.2016

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, CDC, Infections, Outcomes & Safety / 19.09.2016

MedicalResearch.com Interview with: 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. (more…)
Allergies, Author Interviews, Pediatrics / 07.09.2016

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 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. (more…)
Author Interviews, Dermatology, Pharmacology / 15.08.2016

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. (more…)
Author Interviews, Infections, PLoS / 05.08.2016

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 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. (more…)
Author Interviews, Infections, Pharmacology, Urinary Tract Infections / 25.06.2016

MedicalResearch.com Interview with: 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. (more…)