Cystic Fibrosis Patients May Need Higher Doses of Antibiotics To Clear Lung Infections

MedicalResearch.com Interview with:

Andrea Hahn, M.D., MS Infectious disease specialist and lead study author Children's National Health System

Dr. Hahn

Andrea Hahn, M.D., MS
Infectious disease specialist and lead study author
Children’s National Health System

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

Response: People who have the genetic disease cystic fibrosis have increased sticky secretions in their lungs that put them at risk for repeated bacterial infections. They often will receive courses of intravenous antibiotics to treat more severe or difficult-to-treat infections associated with decreased lung function. However, not all patients fully recover their lung function after antibiotic treatment, despite directing antibiotic therapy toward the specific bacteria thought to be causing the infection. The goal of this study was to determine if the pharmacokinetics of commonly used antibiotics was associated with recovery of lung function.

First, we found that patients with therapeutic blood levels of beta-lactam antibiotics had better lung recovery than patients with sub-therapeutic levels of these antibiotics.

Second, we found that using higher antibiotic dosing according to Cystic Fibrosis Foundation guidelines was not sufficient to predict which patients would have therapeutically meaningful blood levels of antibiotics. Continue reading

New Drug Class Holds Promise Against Antibiotic Resistant Gonorrhea

MedicalResearch.com Interview with:

Intracellular Gram-negative, Neisseria gonorrhoeae diplococcal bacteria, - CDC image

Intracellular Gram-negative, Neisseria gonorrhoeae diplococcal bacteria, – CDC image

Edward W. Hook, III, MD
University of Alabama at Birmingham
Medicine / Infectious Diseases
Birmingham, AL

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

Response: Zoliflodacin represents a new class of antibiotics (spiropyrimidinetriones) with in vitro activity against Neisseria gonorrhoeae, as well as other STD  pathogens (Chlamydia trachomatis and Mycoplasma genitalium).  Because of this promising data and the fact that the manufacturer (Entasis Pharmaceuticals) was willing to pursue the possibility of using this drug to treat gonorrhea, a Phase II trial was conducted which showed he drug to be 96% effective for genital or rectal infections.  The drug was well tolerated as well making it a promising drug for gonorrhea treatment which might help to combat the increasing problem of antibiotic resistant gonorrhea.  Continue reading

Tens of Thousands Worldwide Die of Antibiotic-Resistant Bacteria

MedicalResearch.com Interview with:
"Antibiotics" by Michael Mortensen is licensed under CC BY-SA 2.0Dr Alessandro Cassini MD

Epidemiologist, European Centre for Disease Prevention and Control
Solna, Sweden

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

Response: We published an ECDC study estimating attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the European Union and the European Economic Area (EU/EEA). This study is based on 2015 data from the European Antimicrobial Resistance Surveillance Network (EARS-Net).

The study was developed by experts at ECDC and the Burden of AMR Collaborative Group, and published in The Lancet Infectious Diseases.

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Antibiotics and Acid Suppressants May Be Risk Factor For Pediatric Obesity

MedicalResearch.com Interview with:
"babies (365-222)" by Robert Couse-Baker is licensed under CC BY 2.0Dr. Christopher M Stark
Department of Pediatrics
William Beaumont Army Medical Center
El Paso, Texas
Department of Pediatrics
Walter Reed National Military Medical Center
Bethesda, Maryland

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

Response: Rates of pediatric obesity have increased over the past decade, which has led researchers to search for modifiable risk factors that may explain this increase. Recent studies have identified an association between native gut bacteria alterations and the development of obesity. Several population-based studies have evaluated whether or not there is an association between antibiotic exposure and the development of obesity, with mixed results.

No studies have previously evaluated if acid suppressing medications are associated with developing obesity.

We found that young children prescribed antibiotics, acid suppressants, and combinations of these medications in the first two years of life are more likely to develop obesity after two years of age.

Our study represents the largest study to evaluate pediatric antibiotic prescriptions and obesity risk, with nearly ten times as many patients as the next largest study.

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Successful Trial of Cefiderocol For Resistant & Complicated Urinary Tract Infections

MedicalResearch.com Interview with:
https://www.shionogi.com/Simon Portsmouth, MD

Senior Medical Director
Shionogi Inc.

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

Response: Antibiotics for multidrug resistant  Gram-negative infections are desperately needed. Cefiderocol is the first siderophore antibiotic to reach patients.

Siderophore antibiotics bind to free iron and use the bacterial active iron transport channels to cross the outer membrane of Gram-negative bacteria. Laboratory studies have shown that cefiderocol is active against multi-drug resistant Gram-negative bacteria, often where no other antibiotics are active. It is able to overcome most types of antibiotic resistance due to its active transport into cells and stability against all carbapenemases.

The need for antibiotics for carbapenem resistant Gram-negative infections is described as a critical need by the WHO. This trial was the first in humans with serious infections and demonstrated excellent efficacy in a complicated patient population where almost ¼ were over 75 years of age. Additionally cefiderocol did not appear to have any safety problems, and was well tolerated.

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Animal Study Supports Concern Antibiotic Ciprofloxin Increases Risk of Aortic Rupture

MedicalResearch.com Interview with:

Segments of the aorta, including: Thoracic aorta Ascending aorta Tortic arch Descending thoracic aorta Abdominal aorta Suprarenal abdominal aorta Infrarenal abdominal aorta Wikipedia Image

Segments of the aorta, including: Thoracic aorta Ascending aorta Tortic arch Descending thoracic aorta Abdominal aorta Suprarenal abdominal aorta Infrarenal abdominal aorta Wikipedia Image


Scott A. LeMaire, MD
Jimmy and Roberta Howell Professor of Cardiovascular Surgery
Vice Chair for Research, Michael E. DeBakey Department of Surgery
Professor of Molecular Physiology and Biophysics
Director of Research, Division of Cardiothoracic Surgery
Baylor College of Medicine
Department of Cardiovascular Surgery
Texas Heart Institute
Baylor St. Luke’s Medical Center
CHI St. Luke’s Health
Editor-in-Chief, Journal of Surgical Research

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

Response: We performed this study because of concerns about the potential association between fluoroquinolones and aortic aneurysms and dissection raised in two large clinical studies. This concern was noted by the US Food and Drug Administration in May 2016, but the evidence was not deemed sufficient to warrant a warning. Hence, there was a clear need for additional studies to evaluate the problem. Our study was designed to determine whether there is biological evidence that ciprofloxacin—the most commonly prescribed fluoroquinolone—exacerbates aortic disease in a well-established mouse model. The model uses high-fat diet and angiotensin II infusion to stress the aorta and cause aneurysm and dissection. Using this model, we compared mice that received ciprofloxacin to control mice that received only vehicle, and we found that mice that received ciprofloxacin had significant increases in the incidence of aortic dilatation, severe aortic aneurysm and dissection, and aortic rupture and premature death. Importantly, these findings were consistent in male and female mice. Further, we investigated the potential underlying mechanisms and found that the aortas from mice that received ciprofloxacin had decreased levels of lysyl oxidase, increased levels of matrix metalloproteinases, and increased levels of apoptosis and necroptosis. Continue reading

Topical Minocycline Foam for Moderate-to-Severe Acne Meets Phase 3 Study Endpoints

MedicalResearch.com Interview with:
foamixDavid Domzalski
CEO

Foamix Pharmaceuticals

MedicalResearch.com: What is the background for this study?  How does FMX101 differ from other treatment for acne, ie benzoyl peroxide, topical clindamycin etc? 

Response: This study measures the safety and efficacy of a topical foam formulation of the antibiotic minocycline, for the treatment of moderate-to-severe acne.

Minocycline is one of the most commonly used products for the treatment of acne, but is currently only available in an oral dosage form.

Significant side effects are associated with oral minocycline, including GI upset, photosensitivity, headaches, dizziness, and other potential effects on the CNS.  In addition to the side effects associated with oral minocycline, many currently available topical acne medications contain ingredients which can be drying and irritating to the skin.  These side effects can be frustrating to patients and potentially impact overall compliance to their treatment regimen.  The study addresses important unmet needs in dermatology to determine whether providing patients with a topical dosage form of minocycline may have potential advantages over existing products.

In our first two Phase 3 clinical studies, >95% of facial local tolerability signs and symptoms were classified as “none” or “mild,” including dryness, erythema and itching.  Also, our topical minocycline foam, FMX101, is a natural triglyceride-based vehicle that does not contain ingredients that serve as  primary irritants or surfactants.  We believe that FMX101, if approved, would be the first topical minocycline available for the treatment of acne and provide a novel and much needed treatment option for patients who suffer from the physical and psycho-social effects of acne. Continue reading

Bacterial Appendage Offers New Target To Combat Antibiotic Resistance

MedicalResearch.com Interview with:

David G. Thanassi, Ph.D. Professor and Interim Chair Department of Molecular Genetics & Microbiology Center for Infectious Diseases Stony Brook University Stony Brook, NY 11794-5222

Dr. Thanassi

David G. Thanassi, Ph.D.
Professor and Interim Chair
Department of Molecular Genetics & Microbiology
Center for Infectious Diseases
Stony Brook University
Stony Brook, NY 11794-5222

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

Response: Pathogenic bacteria such as Escherichia coli use hair-like surface appendages termed pili to colonize tissues within the host and initiate infection.  Together with our collaborators – the group of Huilin Li at the Van Andel Research Institute – we used an advanced imaging technique termed cryo-electron microscopy to determine snapshots of bacterial pili as they are being assembled.  The pili we studied are critical for uropathogenic strains of E. coli to colonize the urinary tract and cause urinary tract infections.  Our work revealed a new stage in the pilus assembly process and new details about how these structures are built on the bacterial surface.   Continue reading

Bezlotoxumab (Zinplava)For Prevention of Recurrent C. Difficile Infection

MedicalResearch.com Interview with:
Richard Hengel, MD, FRCPC, FACP Atlanta ID Group
Richard Hengel, MD, FRCPC, FACP

Atlanta ID Group

MedicalResearch.com: What is the background for this study? How does Bezlotoxumab differ from other medications for recurrent C. difficile infections?

Response: Clostridium difficile infection (CDI) is now the most common hospital acquired infection in the United States, accounting for significant morbidity and mortality, not only in the US, but around the world. Despite standard antibiotic therapy targeting the Clostridium difficile bacterium directly, recurrent infection is common, occurring in a quarter to a third of patients, often frail individuals with other concurrent medical problems. These patients can have multiple recurrences leading to their progressive deterioration over time. Until recently, the only treatment for CDI included antibiotics. More recently, fecal microbiota transplant is a promising, but as yet, FDA unapproved therapy. Bezlotoximab is a new FDA approved treatment for recurrent Clostridium difficile infection (rCDI) that compliments standard antibiotics. Bezlotoxumab is a monoclonal antibody targeting toxin B produced by Clostridium difficile during CDI. In two large treatment trials, bezotoxumab, in addition to standard-of-care antibiotics, reduced the frequency of CDI recurrences from about 28% to about 18%. In this study, we set out to see if this new drug performed as well in actual clinical practice as it did in the published clinical trials.

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Short Office Visits Linked To More Antibiotic Prescriptions

MedicalResearch.com Interview with:

Dr. Kathryn A. Martinez PhD MPH CanSORT Cancer Surveillance and Outcomes Research Team Cleveland Clinic

Dr Martinez

Dr. Kathryn A. Martinez PhD MPH
CanSORT Cancer Surveillance and Outcomes Research Team
Cleveland Clinic

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

Response: Most upper respiratory infections are viral and therefore should not be treated with antibiotics. Despite this, physicians commonly prescribe them for these conditions. Patients often expect antibiotics for respiratory tract infections.  As a result, physicians may find it easier to give patients what they want rather than explain to them why antibiotics aren’t needed.

We hypothesized it also might be more time consuming for physicians to explain to patients why they don’t need antibiotics, which creates a further incentive to prescribe them. To explore this potential phenomenon, we used data from a large direct to consumer telemedicine system to assess differences in medical encounter length by prescription outcome for patients diagnosed with respiratory tract infections.

We found that encounters resulting in antibiotics were 0.33 minutes shorter than those that resulted in no prescriptions, supporting our hypothesis that prescribing an antibiotic takes less time than prescribing nothing.

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Long Term Antibiotics May Harm Immune Cells of Gut and Mucous Membranes

MedicalResearch.com Interview with:

Pushpa Pandiyan, PhD

Dr. Pandiyan

Pushpa Pandiyan, PhD
Assistant Professor, Biological Sciences
School of Dental Medicine
Case Western Reserve University

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

Response: The objective was to find the role of the resident bacteria in the mouth in controlling oral immunity.

We examined this in a oral fungal infection model. How resident microbiome in the mouth maintains a healthy oral immune system was unknown before.

We found that antibiotics led to destruction of microbiome and some of the good fatty acids the bacteria produced. This created an immune imbalance in the local tissue, thus making the host more susceptible to the fungal infection.  Continue reading

Enzyme Key To Overcoming Antibiotic Resistance in Pseudomonas Infections

MedicalResearch.com Interview with:
"pseudomonas first bacteria to be patented. professor Chakrabarty" by adrigu is licensed under CC BY 2.0Dr Dorival Martins
Department of Microbiology and Immunology
Meakins-Christie Laboratories, Research Institute
McGill University Health Centre
Montreal Canada. 

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

Response: Antibiotic tolerance, together with drug resistance, makes bacteria refractory to antibiotics and can cause treatment failure in subacute and chronic bacterial infections.

Pseudomonas aeruginosa, a major health concern worldwide, can cause severe chronic infections that are refractory to antibiotic treatments due to tolerance. Since the discovery of new antibiotics has been drastically diminished over the last decades, overcoming tolerance could be a strategy to enhance the efficacy of currently available antibiotic treatments. However, very little is known about the mechanism of tolerance, even though this phenomenon has been observed over 60 years ago.

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Antibiotics Leading Cause of Pediatric Adverse Drug Events in ER

MedicalResearch.com Interview with:
Maribeth C. Lovegrove, MPH
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention
Atlanta, GA 30333).

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

Response: There has been a lot of recent attention on reducing unnecessary antibiotic prescribing in order to reduce antibiotic resistance (a longer-term harm).  However, antibiotic use also can lead to shorter-term harms like allergic reactions and other side effects.  With this analysis, we wanted to focus on the acute harms to individual pediatric patients from antibiotic use in order to help target prevention efforts.  Specifically, we used data from two national data sources to identify the antibiotics with the highest numbers of emergency department visits for adverse drug events and the highest rates of emergency department visits for adverse drug events (accounting for amount of antibiotic prescriptions dispensed) and to identify the pediatric patients with the highest risks.

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Antibiotics Still Overprescribed in Many Outpatient Settings

MedicalResearch.com Interview with:

Dr. Katherine Fleming-Dutra, MD, senior author Deputy Director Office of Antibiotic Stewardship CDC

Dr. Fleming-Dutra

Dr. Katherine Fleming-Dutra MD
Deputy Director
Office of Antibiotic Stewardship
CDC

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

Response: Antibiotics are life-saving medications that treat bacterial infections. Any time antibiotics are used, they can lead to antibiotic resistance and could cause side effects such as rashes and adverse events, such as Clostridium difficile infection, which is a very serious and sometimes even fatal diarrheal disease. This is why it is so important to only use antibiotics when they are needed. When antibiotics aren’t needed, they won’t help you and the side effects could still hurt you.

A previous study* reported at least 30% of antibiotic prescriptions written in doctor’s offices and emergency departments were unnecessary. However, the data from that study did not include urgent care centers or retail health clinics. We conducted the current analysis to examine antibiotic prescribing patterns in urgent care centers, retail health clinics, emergency departments, and medical offices.

*Fleming-Dutra, K., et al. (2016). “Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011.” JAMA: the Journal of the American Medical Association 315(17): 1864-1873. https://jamanetwork.com/journals/jama/fullarticle/2518263

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Biomarker Procalcitonin Offered Limited Benefit Over Clinical Judgement In Antibiotic Prescribing Patterns

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

Dr. David Huang

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.

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Widely Use Antibacterial in Hand Sanitizers and Toothpaste Can Attack Biofilms

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 

Dr. Waters

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.

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Ibuprofen Can Not Replace Antibiotics in Uncomplicated UTI

MedicalResearch.com Interview with:

Ingvild Vik MD Doctoral Research Fellow Department of General Practice Institute of Health and Society - UiO University of Oslo, Norway.

Dr. Vik

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.  Continue reading

Clinical Score Predicts Antibiotic Sensitivity to P. aeurginosa  in Hospitalized Patients

MedicalResearch.com Interview with:

Dr. Tom Lodise PharmD, Professor Albany College of Health Sciences, NY

Dr. Tom Lodise

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.

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Some Antibiotics Linked To Increased Risk of Kidney Stones

MedicalResearch.com Interview with:

A kidney stone (yellow) composed of calcium oxalate: Wikipedia Image

A kidney stone (yellow) composed of calcium oxalate: Wikipedia Image

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.

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New Cephalosporin Combination Tested for Complicated Sepsis Patients

MedicalResearch.com Interview with:

Becky Jayakumar, PharmD College of Pharmacy Assistant Professor of Pharmacy Practice Roseman University of Health Sciences

Dr. Jayakumar

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. Continue reading

Merck Tests New Antibiotic Combination For Hard to Treat Bacterial Infections

MedicalResearch.com Interview with:

Amanda Paschke, MD, MSCE Senior principal scientist Infectious disease clinical research Merck Research Laboratories

Dr.Amanda  Paschke

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.  Continue reading

Sinus Infections: Majority of Antibiotic Prescriptions Longer Than Recommended

MedicalResearch.com Interview with:

Dr. Katherine Fleming-Dutra, MD, senior author Deputy Director Office of Antibiotic Stewardship CDC

Dr. Fleming-Dutra

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. Continue reading

Combination Meropenem-Vaborbactam (Vabomere) Successfully Treats Complicated Urinary Tract Infections

MedicalResearch.com Interview with:

Keith S. Kaye, MD, MPH Professor of Medicine, Division of Infectious Diseases University of Michigan Medical School Ann Arbor MI 

Dr. Kaye

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.

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No Reduction In Antibiotic Prescribing Habits

MedicalResearch.com Interview with:

Michael Durkin, MD MPH Washington University School of Medicine St. Louis

Dr. Durkin

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.

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Repeated Less Serious Infections Do Not Affect Children’s School Performance

MedicalResearch.com Interview with:

Ole Köhler-Forsberg, PhD Student Department of Clinical Medicine - Psychosis Research Unit Aarhus University

Ole Köhler-Forsberg

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.  

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