Author Interviews, Cancer Research, Cost of Health Care, ENT, HPV, JAMA, Surgical Research / 18.09.2018

MedicalResearch.com Interview with: Richard B. Cannon, MD Division of Otolaryngology–Head and Neck Surgery School of Medicine University of Utah, Salt Lake City  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The Patient Protection and Affordable Care Act (ACA) is a nationwide effort to reduce the number of uninsured individuals in the United States and increase access to health care. This legislation is commonly debated and objective data is needed to evaluate its impact.  As a head and neck cancer surgeon, I sought to evaluate how the ACA had specifically influenced my patients.  Main findings below:     MedicalResearch.com: What should readers take away from your report? Response: This population-based study found an increase in the percentage of patients enrolled in Medicaid and private insurance and a large decrease in the rates of uninsured patients after implementation of the Patient Protection and Affordable Care Act (ACA).  This change was only seen in states that adopted the Medicaid expansion in 2014. The decrease in the rate of uninsured patients was significant, 6.2% before versus 3.0% after. Patients who were uninsured prior to the Patient Protection and Affordable Care Act had poorer survival outcomes. (more…)
Author Interviews, Infections, Kidney Disease / 18.09.2018

MedicalResearch.com Interview with: Ben Roediger PhD Head of the Skin Inflammation Group within Professor Wolfgang Weninger’s Immune Imaging Laboratory Centenary Institute, Faculty of Medicine and Health, The University of Sydney, Camperdown,, Australia MedicalResearch.com: What is the background for this study? Response: We use several strains of mice for our research, including animals with immunodeficiencies. One of our lines started succumbing to kidney disease and we decided to investigate. (more…)
Author Interviews, Infections, Pulmonary Disease, Stanford / 15.09.2018

MedicalResearch.com Interview with: Stephen J Ruoss MD Professor, Stanford University, Medicine, Division of Pulmonary and Cfritical Care Medicine Stanford, California MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by an atypical mycobacterial infection?  Response: Our interest in undertaking this study stems from three important clinical observations and issues. First, the use of inhaled steroid medications for a broad variety of respiratory complaints and diseases is increasing, including in clinical circumstances where there isn’t much strong supportive evidence for benefit to patients from using inhaled steroids. The second observation is that steroids can and do alter immune system responses, and can increase the risk for some infections. There are already data from studying patients on inhaled steroids where the incidence of bacterial respiratory infections has increased, supporting the concerns for infection risk from inhaled steroids. And the third issue is that steroids can more specifically alter immune system function that helps combat mycobacterial infections, and this means that the risk for, and incidence of mycobacterial infections could be increased in patients treated with inhaled steroids. The best known mycobacterial infection is of course tuberculosis, but there are other mycobacteria, called nontuberculous mycobacterial (or atypical mycobacterial) that are broadly found in the environment, and some of those nontuberculous mycobacteria (NTM) can cause lung infections. So our hypothesis was that the use of inhaled steroids might be associated with an increased frequency of NTM infections, and we designed the study to explore that hypothesis. (more…)
Author Interviews, Cancer Research, Gastrointestinal Disease, Infections / 14.09.2018

MedicalResearch.com Interview with: Nina R. Salama. PhD Member Human Biology Division Member Public Health Sciences Division Affiliate Member Basic Sciences Division Dr. Penny E. Petersen Memorial Chair for Lymphoma Research Director of Molecular and Cellular Biology (MCB) Graduate Program Fred Hutchinson Cancer Research Center  MedicalResearch.com: What is the background for this study? What are the main findings? Response: We wanted to better understand why certain patients infected with H. pylori developed stomach cancer and how we could better identify them. H. pylori is one of the strongest risk factors for stomach cancer, but how much it predisposes individuals to gastric cancer varies around the world. Working closely with colleagues from Zhengzhou University, we ran tests on 49 samples from China and found that 91 percent of patients infected with the EPIYA D gene variant of H. pylori also had stomach cancer. (more…)
Author Interviews, Cost of Health Care, Global Health, Infections, Vaccine Studies / 13.09.2018

MedicalResearch.com Interview with: Veronica Toffolutti PhD Research Fellow in Health Economics Bocconi University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Austerity has been linked to several health damaging effects such as suicides, increase in unmet needs, disease outbreaks that affect vulnerable peoples such as malaria in Greece, HIV in Greece and Romania during the current economic crises or in the earlier economic crisis cuts in public health expenditure have been linked with diphtheria and TB. Europe is experiencing declining vaccination rates and resurgences in measles incidence rates. Italy appears to be particularly affected reporting the second largest number, second to Romania, of infection in Europe in 2017. Starting from the point that the primary reason for the outbreak in the decline in the measles vaccination we test the hypothesis that large budget reductions in public health spending were also a contributing factor. Using data on 20 Italian regions for the period 2000-2014 we found that each 1% reduction in the real per capita public health expenditure was associated with a decrease of 0.5 percentage points (95% CI: 0.36-0.65 percentage points) in MMR coverage, after adjusting for time and regional-specific time-trends.  (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Infections, JAMA / 12.09.2018

MedicalResearch.com Interview with: Patrick Harris FRACP Staff Specialist Microbiology | Pathology Queensland | Health Support Queensland Postdoctoral Research Fellow University of Queensland, UQ Centre for Clinical Research (Paterson Group MedicalResearch.com: What is the background for this study? Response: Increasingly, common bacterial pathogens such as E. coli or Klebsiella have acquired genes known as extended-spectrum beta-lactamases (ESBLs), which mediate resistance to many of our most important antibiotics. Despite their clinical importance, we have limited information derived from randomised clinical trials on the best antibiotic treatments for life-threatening infections caused by these ESBL-producers. We aimed to compare two readily available antibiotics, meropenem (a carbapenem drug, as the “standard of care”) and piperacillin-tazobactam (which may be an alternative to meropenem). Many ESBL-producing bacteria test susceptible to piperacillin-tazobactam in the laboratory, yet clinical efficacy has been uncertain.  Some observational studies have suggested that piperacillin-tazobactam may be effective against ESBL-producers, but the data have been contradictory.  The theory has been that piperacillin-tazobactam may be less likely to select for resistance to carbapenems - which, when it occurs, can result in infection with bacteria that are almost untreatable. (more…)
Author Interviews, JAMA, OBGYNE, STD, USPSTF / 09.09.2018

MedicalResearch.com Interview with: Melissa A. Simon, M.D., M.P.H. Member, U.S. Preventive Services Task Force George H. Gardner professor of clinical gynecology, Vice chair of clinical research Department of Obstetrics and Gynecology Professor of preventive medicine and medical social sciences Northwestern University Feinberg School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: The number of babies born with syphilis is increasing, mirroring the recent increase of syphilis among women. Syphilis infection passed from a pregnant woman to her baby, also known as congenital syphilis, can lead to serious health complications for the baby including premature birth, low birthweight, birth defects, and even death. The Task Force recommends that all pregnant women be screened for syphilis as early in pregnancy as possible to prevent congenital syphilis.  (more…)
Author Interviews, Gastrointestinal Disease, Infections, JAMA, Pediatrics, Vaccine Studies / 07.09.2018

MedicalResearch.com Interview with: Chuanxi Fu, MD.PhD. Professor of Epidemiology, School of Public Health Zhejiang Chinese Medical University Associate editor, Human Vaccines & Immunotherapeutics  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Since 2000, the Lanzhou lamb rotavirus vaccine has been exclusively licensed in China for voluntary rotavirus gastroenteritis prevention, however, the effects of the vaccination on population health, including any indirect impact to unvaccinated individuals have not been evaluated. In the study enrolled 33 407 patients with rotavirus gastroenteritis from 2007 to 2015 seasons in southern China shows vaccination effects in which the median age at onset increased by 4 months, and onset, peak, and cessation of incidence were delayed. The incidence rate ratio among children younger than 4 years and among children ineligible for vaccination decreased as citywide vaccination coverage increased, and the adjusted odds ratio for rotavirus gastroenteritis among unvaccinated infants decreased in areas with higher vaccination coverage.  (more…)
Author Interviews, Heart Disease, Infections, JAMA / 27.08.2018

MedicalResearch.com Interview with: Pr. Didier Raoult Directeur de l'IHU Méditerranée-Infection Marseille  MedicalResearch.com: What is the background for this study? What are the main findings? Response: This work represents the sum of data accumulated over several decades of studies on Q fever. Our reference center contacts each of the physicians in charge and ensures patient follow-up, which allows obtaining data, that is not comparable to those used automatically in databanks. Four people exclusively dedicated their time to manage these specific data on Q fever. The main data confirm the need to perform a cardiac ultrasound for all patients with Q fever and acute endocarditis (to detect valvulopathy) and to give a prophylactic treatment to avoid fixation on the heart in patients with valvulopathy. This work helps clarify the evolution of Q fever by eliminating the term of chronic Q fever, which is based on non-clinical elements, and defining persistent Q fever for which there is an identifiable focus of infection. Furthermore, this work makes it possible to recommend systematic detection of antiphospholipid antibodies in order to limit the risk of thrombosis and the risk of cardiac fixation. (more…)
Allergies, Author Interviews, CDC, Infections, Pediatrics / 25.08.2018

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. (more…)
Author Interviews, HIV, NEJM, Yale / 17.08.2018

MedicalResearch.com Interview with: Brinda Emu, MD Assistant Professor of Medicine (Infectious Diseases) Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: This was a Phase 3 study of a new antiretroviral agent, ibalizumab, for the treatment of HIV-1 infection.  Ibalizumab is a monoclonal antibody that targets the CD4 receptor on host cells.  CD4 is the receptor that HIV uses to infect CD4+ T cells.  By binding to the CD4 receptor, ibalizumab prevents viral entry.  This study recruited patients that harbor multi-drug resistant HIV and were failing their current regimen of antiretroviral agents, and thus had limited options for treatment of their HIV-1 infection using approved medications. (more…)
Author Interviews, HIV, Pharmaceutical Companies / 16.08.2018

MedicalResearch.com Interview with: TaiMed BiologicsStanley Lewis, M.D. TaiMed Biologics Irvine, CA 92614 MedicalResearch.com: What is the background for this study? Response: The phase III clinical trial was conducted to assess the efficacy and safety of Trogarzo™ (ibalizumab-uiyk) injection in patients with multidrug resistant HIV-1. The study design was approved by the FDA. Results obtained were included in the New Drug Application submitted to the FDA which approved Trogarzo™ on March 6, 2018. The phase III, open-label study, enrolled 40 patients with multidrug-resistant (MDR) HIV-1 in whom multiple antiretroviral therapies had failed. All patients at baseline were experiencing viral failure. After a seven-day control period, patients received an intravenous 2000 mg loading dose of Trogarzo™ which was the only change made to their antiretroviral regimen. Through the 24-week treatment period of the study, patients were given a maintenance dose of 800 mg of Trogarzo™ every two weeks along with an optimized background regimen that included at least one additional fully active agent. (more…)
Author Interviews, Cancer Research, Gastrointestinal Disease, HIV, JAMA / 05.08.2018

MedicalResearch.com Interview with: Shan Rajendra MBBCh, MSc , MD, FRCP, FRACP Professor of Medicine University of New South Wales Director of Medicine & Clinical Executive Director Bankstown-Lidcombe Hospital Director Gastro-Intestinal Viral Oncology Group Ingham Institute for Applied Medical Research Sydney  MedicalResearch.com: What is the background for this study?   Response: High-risk human papillomavirus(HPV)  infection has been strongly associated with a subset of Barrett’s dysplasia and oesophageal adenocarcinoma. The research question was; Does HPV status of Barrett’s high-grade dysplasia and esophageal adenocarcinoma influence survival as in viral positive head and neck cancers? We therefore sought to determine the prognostic significance of esophageal tumor HPV status and associated viral transcriptional markers (E6/E7 mRNA and p16INK4A) and TP53. (more…)
Author Interviews, HIV, Merck / 02.08.2018

MedicalResearch.com Interview with: merck Kathleen Squires MD Director, Division of Infectious Diseases Jefferson University Hospitals and Ming-Tai Lai, PhD Senior Principal Scientist, Biology Discover Merck   MedicalResearch.com: What is the background for this study? What are the main findings?  Dr. Squires: The DRIVE-FORWARD study is a pivotal, randomized, double-blind, Phase 3 study that evaluated the safety and efficacy of doravirine (DOR), a non-nucleoside reverse transcriptase inhibitor (NNRTI) in treatment-naïve adults with HIV-1 infection. Data from week 48 of this trial have previously been presented demonstrating that doravirine met its primary endpoint of non-inferior efficacy compared to ritonavir-boosted darunavir (DRV+r). In addition, at 48 weeks, a secondary endpoint showed that the doravirine-treated group had statistically significant lower levels of fasting LDL-C and non-HDL-C versus the DRV+r group. The data presented at AIDS 2018 are week 96 data from the DRIVE-FORWARD trial. At week 96, the doravirine group demonstrated efficacy of 73.1% compared with 66.0% in the DRV+r group, a treatment difference of 7.1% (95% CI: 0.5, 13.7)  Two participants in the DOR treatment group developed genotypic and phenotypic resistance to DOR through 96 weeks of treatment. The rate of discontinuation of therapy due to adverse events was 1.6 percent in the DOR group and 3.4 percent in the DRV+r group. Doravirine is a late-stage investigational NNRTI for the treatment of HIV-1 infection in treatment-naïve adults and is being evaluated both as a once-daily single-entity tablet in combination with other antiretroviral agents, and as a once-daily fixed-dose combination regimen with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF). Earlier this year, Merck announced that the FDA accepted for review two New Drug Applications (NDAs) for doravirine for the treatment of HIV-1 infection in treatment-naïve adults. The NDAs are based upon the findings at week 48 of two ongoing Phase 3 trials, DRIVE-FORWARD and DRIVE-AHEAD, evaluating the efficacy and safety of doravirine and the fixed-dose combination regimen of DOR/3TC/TDF, respectively. The FDA has set a target action date of October 23, 2018 for both applications. Dr. Lai: This study aimed to characterize the mutant viruses selected in treatment-naïve participants through week 48 from DRIVE-FORWARD and DRIVE-AHEAD, and to assess the impact of selected mutations on non-nucleoside reverse transcriptase inhibitor (NNRTI) susceptibility and viral fitness. All of the seven doravirine (DOR)-resistant mutants are either partially susceptible or susceptible to etravirine. Mutants containing the F227C substitution were shown to be hypersusceptible to some nucleoside reverse transcriptase inhibitors (NRTIs) such as azidothymidine (AZT), tenofovir (TFV), lamivudine (3TC), and MK-8591. Among the 12 participants who developed efavirenz (EFV) resistance, 9 of the EFV-resistant clinical mutants were susceptible to DOR with fold-change <2.5. The majority of DOR-selected viruses identified in the treatment-naïve participants in clinical trials to date retain susceptibility to etravirine and hypersensitivity to some NRTIs, with low replication capacity. In addition, the majority of EFV-selected viruses retain susceptibility to DOR.  (more…)
Author Interviews, CDC, Infections / 26.07.2018

MedicalResearch.com Interview with: Dr. Megin Nichols DVM, MPH, DACVPM Lead , Enteric Zoonoses Activity Division of Foodborne, Waterborne, and Environmental Diseases National Center for Emerging and Zoonotic Infectious Diseases CDC Veterinarian MedicalResearch.com: What is the background for this announcement? Response: Each year, CDC and multiple states investigate several multistate outbreaks of Salmonella infections linked to contact with live poultry in backyard flocks. Seventy outbreaks of Salmonella infections have been linked to contact with poultry in backyard flocks since 2000. (more…)
Author Interviews, Flu - Influenza, Genentech / 26.07.2018

MedicalResearch.com Interview with: Mark Eisner MD MPH Mark D. Eisner, MD, MPH Vice President, Product Development Immunology, Infectious Disease, and Ophthalmology Genentech   MedicalResearch.com: What is the background for this study? Would you briefly explain how baloxavir marboxil differs from other flu treatments?  Response: CAPSTONE-2 is a Phase III multicenter, randomized, double-blind study that evaluated a single dose of baloxavir marboxil compared with placebo and oseltamivir in people 12 years and older who are at a high risk of complications from the flu. The high risk inclusion criteria in CAPSTONE-2 were aligned with the Centers for Disease Control and Prevention (CDC), which defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, diabetes or heart disease. For these people, flu can lead to hospitalization or even death. Participants enrolled in the study were randomly assigned to receive a single dose of 40 mg or 80 mg of baloxavir marboxil (according to body weight), placebo or 75 mg of oseltamivir twice a day for five days. The FDA recently accepted a New Drug Application (NDA) and granted Priority Review to baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The NDA was based on results from the Phase III CAPSTONE-1 study of a single dose of baloxavir marboxil compared with placebo or oseltamivir 75 mg, twice daily for five days, in otherwise healthy people with the flu. Results from a placebo-controlled Phase II study in otherwise healthy people with the flu were included as supporting data in the NDA. The FDA is expected to make a decision on approval by December 24, 2018. Baloxavir marboxil is a first-in-class, single-dose investigational oral medicine with a novel proposed mechanism of action designed to target the influenza A and B viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1). Unlike other currently available antiviral treatments, baloxavir marboxil is the first in a new class of antivirals designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication. By inhibiting this protein, baloxavir marboxil prevents viral replication earlier in the flu virus life cycle. (more…)
Author Interviews, HIV, JAMA / 25.07.2018

MedicalResearch.com Interview with: Michael S. Saag, MD Professor,Division of Infectious Diseases UAB MedicalResearch.com: What is the background for this study? What are the main findings? 
  • An update of prior recommendations made by the IAS-USA, which have been updated every 2 years since 1996
  • Cover ARVs for prevention and treatment of HIV infection
  • Developed by an international panel of 16 volunteer experts in HIV research and patient care appointed by the IAS–USA
    • Members receive no compensation and do not participate in industry promotional activities while on the panel
  • Primarily for clinicians in highly resourced settings; however, principles are universally applicable
  • Reviewed data published or presented from September 2016 through June 2018
  • Rated on strength of recommendation and quality of evidence
(more…)
Author Interviews, Global Health, HIV / 25.07.2018

MedicalResearch.com Interview with: Professor Donna Spiegelman ScD Susan Dwight Bliss Professor of Biostatistics Director, Center for Methods in Implementation and Prevention Science (CMIPS)­­­­­­, Yale School of Public Health Professor, Department of Statistics and Data Science, Yale University Director, Interdisciplinary Methods Core, Center for Interdisciplinary Research on AIDS Yale School of Medicine MedicalResearch.com: What is the background for this study? Response: HIV infections can be transmitted from mothers to their infants during pregnancy, childbirth, and  breastfeeding.  Without access to a package of health services that includes antiretroviral medicines and counseling on best breastfeeding practices, it is estimated that 25% of children born to HIV-positive mothers become infected with HIV.In low-resource settings, 50% of these children die before their second birthday. A 32% increase in under-five mortality between 1988 and 2003 prompted the Kenyan government to establish Prevention of Mother to Child Transmission of HIV (PMTCT) programs in over 10,000 health facilities. This achievement was supported by U.S.President’s Emergency Fund for AIDS Relief (PEPFAR), the which contributed over $248 million to PMTCT programs in Kenya between 2004 and 2014. Although this investments in PMTCT coincided with a remarkable halving of Kenya’s under-five mortality rate, it is unknown whether this improvement can be causally attributed to PEPFAR funding for PMTCT. During the 2000s, child mortality decreased across most of sub-Saharan African countries.  These regional trends, rather than PEPFAR funding, may explain all or part of Kenya’s reduction in over 10,000 in child mortality. To help identify whether PEPFAR’s investments in PMTCT made a causal contribution to this reduction in child mortality, we used statistical methods to assess whether the amount or “dose” of PEPFAR funding provided to different provinces in Kenya was associated with increased HIV testing among pregnant women, which is a critical first step in identifying which women need PMTCT, and reduced infant mortality in Kenya. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Infections, JAMA, Pediatrics, University of Pittsburgh / 25.07.2018

MedicalResearch.com Interview with: Idris V.R. Evans, M.D.,MA Assistant Professor Department of Critical Care Medicine University of Pittsburgh MedicalResearch.com: What is the background for this study? What are the main findings? Response: New York State issued a state-wide mandate in 2013 for all hospitals to develop protocols for sepsis recognition and treatment. This mandate was called “Rory’s Regulations” in honor of Rory Staunton, a boy who died from sepsis in 2012. Pediatric protocols involved a bundle of care that included blood cultures, antibiotics, and an intravenous fluid bolus within 1–hour. We analyzed data collected by the NYS Department of Health on 1,179 patients from 54 hospitals and found that the completion of the pediatric bundle within 1 hour was associated with a 40% decrease in the odds of mortality.  (more…)
Author Interviews, Cancer Research, ENT, HPV / 25.07.2018

MedicalResearch.com Interview with: Eric Adjei PhD, MA Saint Louis University Center for Health Outcomes Research (SLUCOR) St. Louis, Missouri  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Survivors of head and neck cancer (HNC) develop second primary cancers (SPCs) at a higher rate than most common cancers. This is concerning because the number of HNC survivors are increasing due to advancements in treatment and technology. Patients whose head and neck cancer was caused by smoking and alcohol are different than those whose HNC were caused by human papillomavirus (HPV). We therefore used data from 2000-2014 National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) 18 database to examine if the incidence and the type of SPC that patients with smoking-related HNC develop were different from those from HPV-related head and neck cancer. First, independent of group of HNC (HPV-related or not), we found that SPCs among survivors of head and neck cancer were high, with about 1-in-8 patients developing an SPC. Additionally, irrespective of whether the index . head and neck cancer was from smoking-related or HPV-related, the majority of SPCs were second malignancies in head and neck region (e.g. tongue, gum, mouth floor etc), lung and esophagus. However, we observed different incidence rates between the two groups. Patients with smoking-related head and neck cancer developed SPCs at a higher rate (14%) than those with HPV-related HNC (10%). (more…)
Author Interviews, HIV, OBGYNE, Pediatrics, Pediatrics, STD / 24.07.2018

MedicalResearch.com Interview with: Monika K. Goyal, M.D., M.S.C.E., senior study author Assistant professor of Pediatrics and Emergency Medicine Children’s National Health System Washington, DC  MedicalResearch.com: What is the background for this study? Response: Patients with pelvic inflammatory disease (PID) are at an increased risk for syphilis and HIV. We know that adolescents account for 20 percent of the 1 million cases of PID that are diagnosed each year. We also know that an estimated one in four sexually active adolescent females has a sexually transmitted infection (STI). While screening for syphilis and HIV is recommended when diagnosing PID, actual screening rates among adolescents have been understudied. This multi-center study aimed to quantify rates of HIV and syphilis screening in young women diagnosed with . pelvic inflammatory disease in pediatric emergency departments and to explore patient- and hospital-specific characteristics associated with screening for these two sexually transmitted infections. (more…)
Author Interviews, Biomarkers, Infections / 21.07.2018

MedicalResearch.com Interview with: David K. Hong, M.D. VP Medical Affairs and Clinical Development at Karius MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Invasive fungal infections (IFI) are a cause of significant mortality and morbidity in immunocompromised patients. The diagnosis of IFIs is challenging, and often requires an invasive biopsy in order to identify the causal pathogen. There is a need for non-invasive methods of fungal identification to help guide targeted anti-fungal therapy. (more…)
Author Interviews, CDC, Infections / 20.07.2018

MedicalResearch.com Interview with: wash-hands-well . CDC wellAaron E. Glatt, MD, FACP, FIDSA, FSHEA Chairman, Department of Medicine & Hospital Epidemiologist South Nassau Communities Hospital Clinical Professor of Medicine Icahn School of Medicine at Mount Sinai Oceanside, NY 11572  MedicalResearch.com: What is the background for the CDC alert regarding a multistate outbreak of multidrug-resistant Salmonella Reading infections linked to raw turkey products?   Is this Salmonella strain different or more dangerous than other Salmonella food poisoning outbreaks?  Response: The CDC has reported that as of yesterday, there have been 90 people infected with Salmonella Reading from 26 states. No deaths have been reported, but 40 patients to date required hospitalization. There was a previous outbreak of S. Reading in 2016 related to contaminated alfalfa sprouts, but this organism is not that much different nor is it more virulent than many other salmonella strains.  (more…)
Author Interviews, CDC, Infections, JAMA / 20.07.2018

MedicalResearch.com Interview with: 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 (more…)
Alzheimer's - Dementia, Author Interviews, Herpes Viruses / 20.07.2018

MedicalResearch.com Interview with: Prof Ruth Itzhaki Emeritus Professor Division of Neuroscience & Experimental Psychology The University of Manchester MedicalResearch.com: What is the background for this study? Response: The background arises from the unexpected discovery, made by my lab almost 30 years ago, that the DNA of the common virus, herpes simplex virus type 1 (HSV1), known as the "cold sore" virus, was present in a high proportion of autopsy brains from elderly humans. Subsequently, we found that HSV1, when in brain of people who have a specific genetic factor, APOE-e4, confers a strong risk of developing Alzheimer's disease. We found also a parallelism with cold sores in that APOE-e4 is a risk for the sores, which occur in about 25-40% of people infected with HSV1. We then looked for links between the effects of HSV1 infection of cells in culture and AD, and found some major associations between virus and disease. Firstly, HSV1 causes an increase in the formation of a small protein called beta amyloid, which is the main component of the abnormal "plaques" seen in Alzheimer's Disease brains. Secondly, we discovered that in AD brains, the viral DNA is located precisely within amyloid plaques, which suggests that the virus is responsible for the formation of these abnormal structures. Thirdly, we confirmed the finding of another lab that HSV1 causes the increased formation of an abnormal form of the protein known as tau, which is the main component of the other characteristic abnormality of Alzheimer's Disease brains - "neurofibrillary tangles". All these discoveries suggested that the damage caused by HSV1 leads eventually to the development of AD. Lastly, we showed that treating HSV1-infected cells in culture greatly reduces the formation of beta amyloid and abnormal tau. This suggests that antiviral agents might be used for treating Alzheimer's Disease patients. (more…)
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, PLoS / 13.07.2018

MedicalResearch.com Interview with: Nine-banded armadillo image credit: Dr. Richard Truman, USPHS, Public Domain (2014)John S. Spencer, Ph.D. Colorado State University Fort Collins, Colorado MedicalResearch.com: What is the background for this study? Where can armadillos be found? What are the main findings?  Response: The ancient disease leprosy, a disease causing skin lesions, nerve damage, disfigurement and disability, is caused by the bacterium Mycobacterium leprae, and is mainly spread by aerosol infection (coughing and sneezing) from human to human. It is rare in the United States (less than 200 cases on average per year), while it is endemic in Brazil, where over 25,000 new cases were diagnosed last year. In addition, zoonotic transmission of leprosy by nine-banded armadillos (Dasypus novemcintus, pictured at left) has been shown to occur in the southern United States, mainly in Texas, Louisiana and Florida. Nine-banded armadillos originated from South America, and expanded their range from Mexico into Texas in the 1800’s, eventually spreading north and east throughout the gulf states. People in Brazil, particularly in rural areas, hunt and kill armadillos as a dietary source of protein. In the small town of Belterra in western Pará state in the Brazilian Amazon region, a survey of 146 residents showed that around 65% of people had some contact with armadillos, through hunting, preparing the meat for cooking, or by eating them. A group of individuals who ate armadillos most frequently (more than once per month and up to twice a week) had a significantly higher antibody titer towards the M. leprae-specific antigen PGL-I and an almost two-fold higher risk of being diagnosed with disease, a significant risk.   (more…)
Author Interviews, Infections / 10.07.2018

MedicalResearch.com Interview with: Thomas A Russo, MD, CM The Departments of Medicine, and Microbiology and Immunology The Witebsky Center for Microbial Pathogenesis University at Buffalo-State University of New York, and the Veterans Administration Western New York Healthcare System Buffalo, New York MedicalResearch.com: What is the background for this study? What is Klebsiella pneumoniae? Response: K. pneumoniae is an important bacterial pathogen that cause a number of different infections. Presently, two pathotypes exist that behave very differently. Classical K. pneumoniae, which is most common in North America and Europe primarily causes infections in the healthcare setting, usually in patients with co-morbidities. Also, it is becoming increasingly antimicrobial resistant, making treatment challenging. Hypervirulent K. pneumoniae, which is more common in the Asian Pacific Rim,  can cause infections in otherwise healthy individuals, often causes infection in multiple sites, and these sites are usually not infected by classical K. pneumonia, such as the eye, brain, and aggressive soft-tissue infection (necrotizing fasciitis). Hypervirulent K. pneumonia strains are also becoming antimicrobial resistant, albeit at a slower rate than classical K. pneumoniae at this time. There are some differences how infections due to these two pathotypes are managed. It would also be ideal to track the prevalence and relative antimicrobial resistance of these two pathotypes, but up until now this could not be reliably done because there was not a validated test that could differentiate them. The goal of this study was to identify biomarkers that could accurately differentiate classical from hypervirulent K. pneumoniae.  (more…)