Author Interviews, Critical Care - Intensive Care - ICUs, Emergency Care, Infections, NEJM, University of Pittsburgh / 21.05.2017

MedicalResearch.com Interview with: Christopher W. Seymour, M.D., M.Sc. Assistant professor of Critical Care Medicine and Emergency Medicine, and member of Clinical Research Investigation and Systems Modeling of Acute Illness University of Pittsburgh MedicalResearch.com: What is the background for this study? What are the main findings? Response: Following the tragic and widely publicized death of Rory Staunton, 12, from undiagnosed sepsis in 2012, New York became the first state to require that hospitals follow a protocol to quickly identify and treat the condition. The mandate led to widespread controversy in the medical community as to whether such steps would have saved Rory or anyone else’s life. Rory’s Regulations require hospitals to follow protocols for early identification and treatment of sepsis, and submit data on compliance and outcomes. The hospitals can tailor how they implement the protocols, but must include a blood culture to test for infection, measurement of blood lactate (a sign of tissue stress) and administration of antibiotics within three hours of diagnosis—collectively known as the “three-hour bundle.” We analyzed data from nearly 50,000 patients from 149 New York hospitals to scientifically determine if  Rory’s Regulations worked. We found that they did - 83 percent of the hospitals completed the bundle within the required three hours, overall averaging 1.3 hours for completion. For every hour that it took clinicians to complete the bundle, the odds of the patient dying increased by 4 percent. (more…)
Author Interviews, Critical Care - Intensive Care - ICUs, Electronic Records, Infections / 21.05.2017

MedicalResearch.com Interview with: Faheem Guirgis MD Assistant Professor of Emergency Medicine Department of Emergency Medicine Division of Research UF Health Jacksonville MedicalResearch.com: What is the background for this study? What are the main findings? Response: Sepsis is quite prevalent among hospitals and the incidence is increasing. It is a life-threatening disease that can lead to poor outcomes if patients are not recognized and treated promptly. We recognized that our institution needed a strategic approach to the problem of sepsis, therefore the Sepsis Committee was created with the goal of creating a comprehensive sepsis program. We developed a system for sepsis recognition and rapid care delivery that would work in any area of the hospital. We found that we reduced overall mortality from sepsis, the number of patients requiring mechanical ventilation, intensive care unit length and overall hospital length of stay, and the charges to the patient by approximately $7000 per patient. (more…)
Author Interviews, Infections, Vaccine Studies / 15.05.2017

MedicalResearch.com Interview with: AbivaxJean-Marc Steens, M.D. Chief Medical Officer of Abivax MedicalResearch.com: What is the background for this study? What are the main findings? Response: Antiretroviral therapy (ART) has had an enormous impact on the HIV pandemic since its introduction almost 20 years ago. Most patients treated with ART achieve undetectable or near undetectable plasma levels of the virus. This means that although HIV is controlled, it is not completely eliminated. The virus remains in the body, usually contained in dormant cells (known as the HIV reservoir) that are widely distributed, including to the central nervous system, the gut mucosa, the lymph nodes and other sites. If ART is stopped, the virus rebounds. The goal of any curative therapy would be to eliminate the virus or ensure there is sustained remission in the absence of ART, which until now have been unsuccessful. Abivax’s Phase 2 clinical study with ABX464 demonstrated, for the first time, a reduction in HIV reservoirs in chronically infected HIV patients as measured by total HIV DNA detected in peripheral blood mononuclear cells (PBMCs). In the ABX464-004 trial, 30 HIV patients received either ABX464 or matching placebo in addition to their current antiretroviral treatment over 28 days. The viral load at the start of the study was well controlled with boosted darunavir. After the 28-day treatment period, all treatments were interrupted until viral load rebound. Baseline and day 28 blood samples were taken to assess the potential effect of ABX464 on the HIV reservoir in PBMCs. Safety was the primary endpoint in the trial. ABX464 was well tolerated, with no severe adverse events in the treatment group. Amongst evaluable patients (4 placebo and 14 ABX464-treated patients), a reduction in viral DNA copies/mPBMCs was observed in 7/14 treated patients (mean change of -40%, ranging from -27% to -67%) and no responders were observed in the placebo group. Responders were defined as patients who had a decrease greater than 25% in total HIV DNA in PBMCs and a reduction of at least 50 copies. Total HIV DNA in PBMC has been validated as a widely accepted biomarker for measuring the HIV reservoir. Specifically, in untreated patients, total HIV DNA load influences the course of the infection and is therefore clinically relevant. In addition, a correlation exists between the pool of HIV-1 DNA and the replication-competent reservoir. (more…)
Author Interviews, Infections, Respiratory, Vaccine Studies / 12.05.2017

MedicalResearch.com Interview with: Nima Farzan Chief Executive Officer & President of PaxVax MedicalResearch.com: What is the background for this study? What are the main findings? Response: PaxVax is developing a new and improved version of the vaccine, known as the Modernized Production Adenovirus Vaccine (MPAV) Prototype A. The Company was chosen as the Small Business Innovation Research and Regulatory Sponsor for the development of the Modernized Production Adenovirus Vaccine (MPAV) Prototype A due to the company’s prior experience working with multiple strains of Adenovirus. An Investigational New Drug (IND) application for MPACV was submitted to the U.S. Food and Drug Administration (FDA) on January 30, 2017. The Phase I clinical trial has been initiated and will be conducted at the Larner College of Medicine at the University of Vermont and Cincinnati Children’s Hospital. PaxVax expects to see results of the Phase I clinical trial in early 2018. Complications of adenovirus 4/7 can include headache, pneumonia, sore throat and eye infections. In severe cases, adenovirus can lead to acute respiratory distress syndrome and other serious complications related to organ system damage (including GI tract and bladder) that can result in death, if left untreated. (more…)
Author Interviews, C. difficile, Infections, Microbiome / 09.05.2017

MedicalResearch.com Interview with: Sheila Connelly, PhD Vice President, Research Synthetic Biologics, Inc. MedicalResearch.com: What is the background for this study? Response: Synthetic Biologics, Inc. is focused on the protection and preservation of the gut microbiome which is the diverse collection of microorganisms that live in the intestinal tract. We are learning that the gut microbiome plays a key role in health. Negative changes to the microbiome, called dysbiosis, are linked to disease states including allergies, autism, and obesity, among a rapidly growing list of other conditions. A consequence of using antibiotics is that, in addition to fighting the bacterial infection being treated, they also kill the gut microbiota. The space left in the gut by the dead bacteria allows other surviving bacteria, many times opportunistic pathogens or microbes that are resistant to multiple antibiotics, to overgrow and fill the open niches. Exposure to antibiotics, particularly broad-spectrum antimicrobials, such as penicillins and cephalosporins, is a major risk factor for acquiring a potentially deadly Clostridium difficile infection. Another consequence of antibiotic use is the emergence of antibiotic-resistant organisms. Widespread use of antibiotics provides selective pressure for the evolution of lethal, multi-drug resistant pathogens, termed “nightmare bacteria”. The gut microbiome acts as a reservoir of antibiotic resistance that can be triggered, by antibiotic exposure, to acquire and propagate resistance genes. A way to protect the microbiome and reduce antibiotic resistance is to limit exposure of the gut microbiota to antibiotics. To this end, we developed an antibiotic inactivation strategy using a beta-lactamase enzyme to degrade beta-lactam antibiotics in the GI tract before they can harm the gut microbiome. Beta-lactamases are naturally-occurring bacterial enzymes that confer resistance to beta-lactams, the most widely used broad spectrum antibiotics, and their presence is normally considered an obstacle to efficacious infection control. We took advantage of the highly efficient antibiotic degradation activity of a beta-lactamase and developed SYN-004 (ribaxamase). Ribaxamase is a beta-lactamase engineered to inactivate penicillins and most cephalosporins, formulated for oral delivery, and intended for use with IV beta-lactam antibiotics to degrade the antibiotics in the GI tract to protect the microbiome. Ribaxamase was demonstrated to significantly reduce the occurrence of C. difficile disease in a recently completed Phase 2b clinical study. The study met its primary endpoint by demonstrating that ribaxamase, when delivered orally with IV ceftriaxone, significantly reduced C. difficile disease in patients treated for a respiratory tract infection. Ribaxamase also resulted in a significant reduction in new colonization by vancomycin-resistant enterococcus (VRE). For the current study, pig models of antibiotic-mediated gut dysbiosis were established using three classes of beta-lactam antibiotics, a cephalosporin, ceftriaxone, a penicillin, amoxicillin, and a carbapenem, ertapenem. The ceftriaxone model was used to evaluate the protective effect of ribaxamase on the microbiome and the amoxicillin and ertapenem models are intended for evaluation of pipeline products. (more…)
Author Interviews, Dengue, Vaccine Studies / 04.05.2017

MedicalResearch.com Interview with: Dr Vianney Tricou DPhil Takeda Vaccines Singapore MedicalResearch.com: What is the background for this study? What are the main findings? Response: Dengue fever is a painful, debilitating mosquito-borne disease caused by any one of four closely related dengue virus serotypes, and persons living in dengue endemic regions may be affected by dengue more than once in their lifetime. Some individuals with dengue fever are hospitalized and may need intensive therapy to prevent shock and death, and severe dengue is a leading cause of hospitalization and death among children and adults in some Asian and Latin American countries. About half of the world’s population lives under the threat of dengue and the disease has a significant medical and economic impact in the tropical and subtropical regions of the world where dengue is endemic. Takeda is committed to improving global public health and to developing a life-saving dengue vaccine candidate for people around the world. Takeda’s tetravalent dengue vaccine candidate (TAK-003) is based on a live-attenuated dengue serotype 2 virus (DENV-2), which provides the genetic ‘backbone’ for all four attenuated dengue virus serotypes present in the vaccine. Takeda’s Phase 1 and Phase 2 clinical study program includes 8 studies to date that assess the safety and/or immunogenicity of this candidate, before moving into Phase 3. Takeda’s ongoing Phase 2 DEN-204 study is designed to assess the safety and immunogenicity of one- and two-dose schedules of TAK-003 in 1,794 healthy children and adolescents ages two through 17 years living in dengue-endemic countries in Latin America and Asia. As published in The Lancet Infectious Diseases in March 2017, an interim analysis of DEN-204 data indicated that TAK-003 elicited antibody responses to all four dengue serotypes in the population studied, regardless of whether they had previous dengue exposure. A second TDV dose improved antibody responses against DENV-3 and DENV-4 in children who were seronegative before vaccination. In this study, the safety profile was consistent with that observed in earlier Phase 1 and 2 studies. (more…)
Author Interviews, Respiratory / 04.05.2017

MedicalResearch.com Interview with: Harri Hemilä, MD, PhD Department of Public Health University of Helsinki MedicalResearch.com: What is the background for this study? What are the main findings? Response: Some zinc lozenges intended for treating the common cold have contained zinc acetate and some others have contained zinc gluconate. There have been proposals that zinc acetate might be more optimal salt for lozenges than zinc gluconate. Therefore I compared the randomized trials that have used zinc acetate with zinc gluconate to see if there is difference between the lozenges. Although the average effect in 3 studies with zinc acetate lozenges was greater (40%) than the average effect in 4 studies with zinc gluconate lozenges (28%), that difference was explained by random variation. I also analyzed the dose dependency of the effect and found that 2 studies that used 192 and 207 mg per day elemental zinc did not find greater benefit than 5 studies that used 80 to 92 mg per day zinc. The overall average effect of zinc lozenges was 33% reduction in common cold duration and that effect seems to be reached with doses less than 100 mg per day. (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, HIV, JAMA, Pediatrics, Sexual Health / 25.04.2017

MedicalResearch.com Interview with: Robin Lin Miller, Ph.D. Professor, Ecological-Community Psychology Co-Director, MA in Program Evaluation Chair, Graduate Program in Ecological-Community Psychology Michigan State University East Lansing, MI 48824 MedicalResearch.com: What is the background for this study? Response: We wanted to identify promising strategies for providing access to HIV-testing for gay and bisexual male youth. We were especially interested in testing strategies to reach gay and bisexual male youth of color, as they bear a disproportionate burden of the HIV epidemic and are the least likely to be aware of their HIV status. We also wanted to explore approaches to successfully link these youth with HIV-negative test results to diverse HIV prevention services, including pre-exposure prophylaxis, when warranted. Although some argue that the ideal place to test adolescents and young adults is via emergency rooms and in routine medical care visits, we found that we were able test many more youth with previously undiagnosed HIV-infection through intensive, targeted community outreach efforts. We also tested a much higher proportion of young men of color through targeted outreach. (more…)
Addiction, Author Interviews, Infections, JAMA, Ophthalmology / 22.04.2017

MedicalResearch.com Interview with: Aubrey Tirpack, PGY3 New England Eye Center Tufts Medical Center  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Intravenous drug abuse is a known risk factor for the development of endogenous fungal endophthalmitis (EFE), a severe intraocular infection cause by the seeding of mycotic organisms to the eye. Our institution noted a marked increase in cases of EFE beginning in May 2014, which correlates to increasing rates of opioid abuse throughout the New England region. Ten patients were found to have intravenous drug abuse related EFE over the two year time period studied. The most common presenting symptoms were floaters, decreased vision, and pain. All patients were treated with systemic antifungals and nine patients underwent intravitreal antifungal injection. All patients were ambulatory at presentation and the majority were without systemic signs of infection. (more…)
Author Interviews, CDC, Infections / 22.04.2017

MedicalResearch.com Interview with: Ms. Ellyn Marder MPH Surveillance Epidemiologist, CDC Centers for Disease Control and Prevention Atlanta, Georgia MedicalResearch.com: What is the background for this study? What are the main findings? Response: CDC’s Foodborne Diseases Active Surveillance Network (FoodNet) report provides the most up-to-date information about foodborne illnesses in the United States. Each year, FoodNet publishes a report that includes preliminary data compared with data from the previous three years. FoodNet has been monitoring illness trends since 1996 and collects data on about 15 percent of the U.S. population. Campylobacter and Salmonella caused the most reported bacterial foodborne illnesses in 2016, according to preliminary data. FoodNet sites alone reported 24,029 foodborne infections, 5,512 hospitalizations, and 98 deaths in 2016. The numbers of reported illnesses by germ are: Campylobacter (8,547), Salmonella (8,172), Shigella (2,913), Shiga toxin-producing E. coli (1,845), Cryptosporidium (1,816), Yersinia (302), Vibrio (252), Listeria (127) and Cyclospora (55). This is the first time the report also includes in the total number of infections those foodborne bacterial infections diagnosed only by rapid diagnostic tests in FoodNet sites. Previously, the report counted foodborne bacterial infections confirmed only by traditional culture-based methods in the total numbers. (more…)
Author Interviews, Heart Disease, HIV, JAMA, Vanderbilt / 18.04.2017

MedicalResearch.com Interview with: Matthew S Freiberg, MD, MSc Associate Professor of Medicine, Division of Cardiovascular Medicine Vanderbilt Translational and Clinical Cardiovascular Research Center MedicalResearch.com: What is the background for this study? Response:  HIV infected people are living longer and are at risk for cardiovascular diseases. While acute myocardial infarction has been studied and the increased risk of Acute Myocardial Infarction (AMI) among HIV+ people compared to uninfected people is well documented, there are less data describing the risk of HIV and different types of heart failure, including reduced and preserved ejection fraction heart failure. Understanding more about the link between HIV and different types of HF is important because reduced and preserved ejection fraction heart failure differ with respect to underlying mechanism, treatment, and prognosis. Moreover, as cardiovascular care has improved, HIV infected people who experience an AMI are likely to survive but may live with a damaged heart. Understanding more about the link between HIV and heart failure may help providers and their patients prevent or reduce the impact of HF on the HIV community. (more…)
Author Interviews, Nature, Zika / 14.04.2017

MedicalResearch.com Interview with: Dr. Jikui Song PhD Assistant professor of biochemistry University of California, Riverside. MedicalResearch.com: What is the background for this study? What are the main findings? Response: Recent outbreak of Zika virus (ZIKV) has become a wordwide health concern. However, no vaccines or antiviral drugs against ZIKV are currently available. To explore potential druggable sites for ZIKV, we set out to determine the crystal structure of full-length ZIKV NS5, the molecular machinery responsible for the genomic replication of ZIKV. The major findings of our study include the identification of a conserved domain conformation within flavivirus NS5 family, which may be important for functional regulation of flavivirus NS5. Furthermore, our structural analysis revealed a potential drug-binding site of ZIKV NS5, providing basis for future development of novel antivirals against ZIKV. (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, Global Health, Infections / 02.04.2017

MedicalResearch.com Interview with: Dr Mihály Sulyok MD Eberhard Karls University Institute of Tropical Medicine, Tübingen, Germany MedicalResearch.com: What is the background for this study? What are the main findings? Response: New antimalarials are desperately needed, not just for treatment, but also for prophylaxis. DSM265, a novel antimalarial compound that selectively inhibits the plasmodial dihydroorotate dehydrogenase has a promising pharmacokinetic profile characterized by a long elimination half-life. We performed a study at the Institute of Tropical Medicine, Eberhard Karls University (Tübingen, Germany) to investigate safety, tolerability and efficacy of DSM265 using controlled human malaria infection. In the first cohort, 400mg of DSM265 was administered orally to five healthy, malaria naive individuals one day before direct venous inoculation of an established infective dose of P. falciparum sporozoites (PfSPZ Challenge). Placebo was administered to two volunteers. The study was randomized and double blinded. In this cohort all placebo participants developed malaria, whereas all DSM265 participants were protected. In a second cohort, 400mg DSM265 was administered 7 days before the sporozoite inoculation for six participants, two participants recieved placebo. In this cohort, the two placebo and three of six DSM265 volunteers developed thick blood smear positive malaria. The remaining three DSM265 volunteers developed transient submicroscopic parasitemia without symptoms or thick blood smear positivity. The only possible DSM265-related adverse event was a slight transient elevation in serum bilirubin in one volunteer. The study was funded by the Global Health Innovative Technology Fund, Wellcome Trust, Bill & Melinda Gates Foundation through Medicines for Malaria Venture, and the German Center for Infection Research. (more…)
Author Interviews, Zika / 31.03.2017

MedicalResearch.com Interview with: Daihai He PhD Department of Applied Mathematics The Hong Kong Polytechnic University Hung Hom, Kowloon Hong Kong (SAR), China MedicalResearch.com: What is the background for this study? What are the main findings? Response: Zika virus disease has large outbreaks in many Pacific and American countries in 2016, and the outbreaks are still on-going. Our work is conducted against this background. We compared data from three localities: French Polynesia in 2013-2014, Colombia and Brazil in 2016. We found that in French Polynesia the infection attack rate (i.e. the proportion of the population who got infected) is about 3/4, which matched previous serological studies. We then make estimation for the other two place. We found that the infection attack rate in Colombia in 2016 was most likely less than 50%. For Bahia province of Brazil, we did not arrive at a very accurate estimation, as the confidence interval is wide, and our best estimate is 30%. The relatively low infection attack rate in Colombia and Brazil implies that future outbreaks of Zika virus diseases are still possible. Thus control and surveillance efforts should be continued. (more…)
Author Interviews, HPV, NEJM, OBGYNE, Vaccine Studies / 30.03.2017

MedicalResearch.com Interview with: Anders Hviid Senior Investigator, M.Sc.,Dr.Med.Sci. Department of Epidemiology Research Division of National Health Surveillance & Research MedicalResearch.com: What is the background for this study? Response: HPV vaccination targeting girls and young women has been introduced in many countries throughout the world. HPV vaccines are not recommended for use in pregnancy, but given the target group, inadvertent exposure will occur in early unrecognized pregnancies. However, data on the safety of HPV vaccination in pregnancy is lacking. (more…)
Author Interviews, C. difficile, Gastrointestinal Disease, JAMA, Mayo Clinic / 29.03.2017

MedicalResearch.com Interview with: Sahil Khanna, M.B.B.S. MS Division of Gastroenterology and Hepatology Mayo Clinic, Rochester, Minnesota MedicalResearch.com: What is the background for this study? What are the main findings? Response: Clostridium difficile infection (CDI) is the most common cause of hospital-acquired diarrhea and has recently shown increasing incidence especially in the community. Novel risk factors for CDI development include the use of gastric acid suppression medication, presence of systemic comorbid conditions, C difficile carriage in water and food sources, amongst others. Gastric acid suppression medications such as proton-pump inhibitors (PPIs) and histamine-2 receptor blockers (H2Bs) are commonly prescribed and consumed over the counter for gastroesophageal reflux disease, peptic ulcer disease, or functional dyspepsia, but they are also sometimes prescribed for unnecessary indications, which leads to overuse of these medications. Recurrent CDI after a primary infection is a major problem, with the risk being as high as 50% to 60% after 3 or more Clostridium difficile infections. Data on the association between acid suppression and recurrent CDI are conflicting and therefore we performed a systematic review and meta-analysis to study the association between the use of gastric acid suppression medications and the risk of recurrent CDI. (more…)
Author Interviews, Brigham & Women's - Harvard, HIV, Pediatrics / 28.03.2017

MedicalResearch.com Interview with: Anne M Neilan, MD,MPH Assistant in Medicine and Pediatrics Massachusetts General Hospital Instructor at Harvard Medical School Department: Medicine Service Division: Infectious Disease Department: Pediatric Service Massachusetts General Hospital Boston, MA 02114 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Adolescents infected with HIV – either at birth or later in life – experience poorer health outcomes compared to adults with HIV in nearly every respect. This study found that U.S. youth infected with HIV around the time of their birth are at higher risk throughout their adolescence and young adulthood for experiencing serious health problems, poor control of the HIV virus (having high levels of HIV virus in their bodies and fewer CD4 immune cells which protect the body from infection), or death. The study also found that among those with good HIV control, serious health problems are rare. By combining data from two large, long-term U.S. studies – the Pediatric HIV/AIDS Cohort Study (PHACS, www.phacsstudy.org) and the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT, www.impaactnetwork.org) Network – we were able to study the health of more than 1,400 perinatally HIV-infected children, adolescents and young adults ages 7 to 30 years between 2007 and 2015. The study found that youth ages 13 to 30 were most likely to have poor HIV control AIDS-related illnesses, and death compared to younger participants. Among 18 – 30 year-olds, the study found that poor control of the HIV virus – meaning higher levels of HIV virus and lower levels of CD4 immune cells which protect the body from infection –35 percent of the time, increasing the risk that these youth would stop responding to certain HIV medications and could transmit HIV to others. These findings are consistent with other U.S. and European reports. Despite being engaged in health care, the number of deaths among youth born with HIV in the U.S. is 6 to12 times higher than for youth without HIV of the same age, sex and race. Along with HIV-related health problems, the most commonly reported health conditions concerned mental health and brain and nervous system development. Many women in the study also had sexually transmitted infections, which was found to be associated with lower CD4 immune cell counts. This may suggest a biological mechanism or may reflect that patients who have difficulty with their medications are also engaging in more frequent risky sexual behaviors. (more…)
Author Interviews, CDC, HIV, Sexual Health / 23.03.2017

MedicalResearch.com Interview with: Qian An, PhD Epidemiologist/statistician Division of HIV/AIDS Prevention CDC MedicalResearch.com: What is the background for this study? Response: Since 2006, the Centers for Disease Control and Prevention (CDC) has recommended HIV testing for all persons aged 13-64 years old. Persons at high risk for HIV infection should be tested more frequently. Among sexually active men who have sex with men (MSM), repeat testing is recommended at least annually. An analysis in 2011 suggested that MSM might benefit from more frequent than annual testing.(1) Among non-MSM, repeat testing is recommended at least annually for persons at high risk, including persons who inject drugs (PWID) and their sex partners, those who have sex in exchange for money or drugs, heterosexuals who have had more than one sex partner since their most recent HIV test, and those whose partners are living with HIV.. Using statistical models based on renewal theory, we estimate the mean HIV inter-test interval (ITI) — meaning the average time period (in months) between two successive HIV tests — to describe temporal trends in HIV testing frequency among MSM, PWID and high-risk heterosexuals (HRH) and differences in testing frequency by age and race/ethnicity. A decrease in ITI means individuals are testing more frequently. (more…)
Author Interviews, C. difficile, Gastrointestinal Disease, Microbiome, Transplantation / 14.03.2017

MedicalResearch.com Interview with: Dr. H. L. DuPont MD Director, Center for Infectious Diseases, UTHealth School of Public Health Mary W. Kelsey Chair in the Medical Sciences, McGovern Medical School at UTHealth Professor, Department of Epidemiology, Human Genetics and Environmental Sciences UTHealth School of Public Health Houston, TX 77030 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Many diseases and disorders are associated with “dysbiosis,” where the intestinal microbiota diversity is reduced. This contributes to disease and to the acquisition of antibiotic resistance. Fecal microbiota transplantation (FMT) is successful in conditions with pure dysbiosis (e.g. C diff infection) and a single dose of FMT is curative in most cases. (more…)
Author Interviews, Hospital Acquired, Outcomes & Safety / 02.03.2017

MedicalResearch.com Interview with: Curtis J. Donskey, MD Geriatric Research, Education, and Clinical Center Cleveland Veterans Affairs Medical Center Cleveland, OH 44106 MedicalResearch.com: What is the background for this study?  Response: Many hospitals are making efforts to improve cleaning to reduce the risk for transmission of infection from contaminated environmental surfaces. Most of these efforts focus on surfaces like bed rails that are frequently touched by staff and patients. Despite the fact that floors have consistently been the most heavily contaminated surfaces in hospitals, they have not been a focus of cleaning interventions because they are rarely touched. However, it is plausible that bacteria on floors could picked up by shoes and socks and then transferred onto hands. In a recent study, we found that when a nonpathogenic virus was inoculated onto floors in hospital rooms, it did spread to the hands of patients and to surfaces inside and outside the room. Based on those results, we assessed the frequency of floor contamination in 5 hospitals and examined the potential for transfer of bacteria from the floor to hands. (more…)
Author Interviews, CDC, Fertility, Sexual Health, STD / 01.03.2017

MedicalResearch.com Interview with: Dr. Kristen Kreisel PhD Epidemiologist at Centers for Disease Control and Prevention Centers for Disease Control and Prevention MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pelvic inflammatory disease (PID), an infection of the female reproductive tract often associated with STDs, is putting millions of women at risk for infertility, ectopic pregnancy and chronic pelvic pain. Our study looked at data from the National Health and Nutrition Examination Survey to estimate the national burden of PID. Findings show an estimated 4.4 percent of sexually-experienced women aged 18-44, or approximately 2.5 million woman nationwide reported a history of PID. (more…)
Author Interviews, BMJ, Flu - Influenza, Karolinski Institute, OBGYNE, Pediatrics, Pharmacology / 01.03.2017

MedicalResearch.com Interview with: Dr. Sophie Graner Department of Women's and Childrens Health Karolinska Institute, Stockholm, Sweden MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pregnant women are at increased risks of severe disease and death due to influensa infection, as well as hospitalization. Also influenza and fever increase the risk of adverse pregnancy outcomes for their infants such as intrauterine death and preterm birth. Due to this, the regulatory agencies in Europe and the US recommended post exposure prophylaxis and treatment for pregnant women with neuraminidase inhibitors during the last influenza pandemic 2009-10. Despite the recommendations, the knowledge on the effect of neuraminidase inhibitors on the infant has been limited. Previously published studies have not shown any increased risk, but they have had limited power to assess specific neonatal outcomes such as stillbirth, neonatal mortality, preterm birth, low Agar score, neonatal morbidity and congenital malformations. (more…)
Author Interviews, HIV, Pharmacology / 20.02.2017

MedicalResearch.com Interview with: Kati Vandermeulen Senior Director, Global Regulatory Leader and Compound Development Team Lead IDV Janssen MedicalResearch.com: What is the background for this study? What are the main findings? Response:  SWORD is the first large trial program specifically conducted to look at the combination of dolutegravir and rilpivirine as a complete, two-drug antiretroviral regimen. Results of the two identical Phase III SWORD studies have been positive and demonstrate that the two-drug regimen of dolutegravir and rilpivirine is as effective, with comparable tolerability, to traditional three- or four-drug (integrase inhibitor-, non-nucleoside reverse transcriptase inhibitor-, or boosted protease inhibitor-based) antiretroviral regimens for the maintenance treatment of HIV. (more…)
Author Interviews, Neurological Disorders, Zika / 19.02.2017

MedicalResearch.com Interview with: Ping Wu, MD, PhD John S. Dunn Distinguished Chair in Neurological Recovery Professor, Department of Neuroscience & Cell Biology University of Texas Medical Branch Galveston, TX 77555-0620 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Zika viral infection poses a major global public health threat, evidenced by recent outbreaks in America with many cases of microcephaly in newborns and other neurological impairments. A critical knowledge gap in our understanding is the role of host determinants of Zika-mediated fetal malformation. For example, not all infants born to Zika-infected women develop microcephaly, and there is a wide range of Zika-induced brain damage. To begin to fill the gap, we infected brain stem cells that were derived from three human donors, and found that only two of them exhibited severer deficits in nerve cell production along with aberrant alterations in gene expression. (more…)
Author Interviews, Global Health, HIV, Lancet / 19.02.2017

MedicalResearch.com Interview with: Jennifer A. Downs, M.D., Ph.D. Assistant Professor of Medicine and Microbiology & Immunology Department of Medicine Weill Cornell Medicine Center for Global Health New York, NY 10065 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Between 2002 and 2006, three large randomized controlled trials in sub-Saharan Africa demonstrated that male circumcision reduces new HIV infections in men by approximately 60%. Based on these findings, the World Health Organization recommended male circumcision as an HIV prevention strategy in countries with high levels of HIV and a low prevalence of male circumcision. This led to prioritization of 14 countries in Eastern and Southern Africa for massive scale-up of male circumcision beginning in 2011. In many of these countries, the uptake of male circumcision was lower than expected. In northwest Tanzania, where we work, there are a number of barriers to male circumcision. Some of these barriers are cultural, tribal, economic, and religious. We conducted focus group interviews in 2012 that showed that many Christian church leaders and church attenders in our region in Tanzania had major concerns about whether male circumcision was compatible with their religious beliefs. This led us to hypothesize that the uptake of male circumcision could be increased when religious leaders were taught about male circumcision, with the goal that they would then be equipped to discuss this issue with their congregations. (more…)
Author Interviews, HIV, Immunotherapy / 17.02.2017

MedicalResearch.com Interview with: Brinda Emu MD Assistant Professor of Medicine (Infectious Diseases Yale University New Haven, CT  MedicalResearch.com: What is the background for this study? Response: Ibalizumab is a fully humanized monoclonal antibody that targets the CD4 receptor.  This Phase III registrational study enrolled individuals with HIV infection that harbor high levels of multi-drug resistance, with limited treatment options.  At IDWeek in October, 2016, data was presented that demonstrated patients experienced a significant decrease in viral load after receiving a single loading dose of ibalizumab 2,000 mg intravenously (IV) in addition to their failing antiretroviral therapies (ART) (or no therapy). Seven days after this loading dose, 83% of patients achieved a ≥ 0.5 log10 decrease from baseline compared with 3% during the seven-day control period .These results were statistically significant (p<0.0001). At CROI, additional data on the Week 24 results from this study are now presented. (more…)
Author Interviews, CDC, NEJM, Zika / 16.02.2017

MedicalResearch.com Interview with: Gabriela Paz-Bailey MD PhD Senior Epidemiologist Centers for Disease Control and Prevention  MedicalResearch.com: What is the background for this study? Response: Zika virus is recognized as a cause of microcephaly and other severe birth defects when a woman is infected during pregnancy. Additionally, it has been associated with potentially fatal complications, such as Guillain-Barré syndrome. It is not well understood how often Zika virus particles can be detected in semen and other body fluids and for how long they remain detectable. Existing evidence is based on case reports and cross-sectional observations, primarily from returning travelers. A more comprehensive description of the dynamics of the early stages of Zika virus infection, observed within infected people over time, is needed to inform diagnostic testing as well as prevention recommendations and interventions. (more…)