Infectious Prions Detected in Skin of Patients With Neurodegenerative Creutzfeldt-Jakob Disease

MedicalResearch.com Interview with:

The brain of one patient who died from sporadic Creutzfeldt-Jacob disease (sCJD) appears nearly identical to the brain of a mouse inoculated with infectious prions taken from the skin of patients who died from sCJD.

The brain of one patient who died from sporadic Creutzfeldt-Jacob disease (sCJD) appears nearly identical to the brain of a mouse inoculated with infectious prions taken from the skin of patients who died from sCJD.
Case Western Reserve University

 

Byron Caughey, Ph.D.
Senior Investigator
Chief, TSE/prion Biochemistry Section
Laboratory of Persistent Viral Diseases
NIH/NIAID Rocky Mountain Laboratories
Hamilton, MT 

 

 

MedicalResearch.com: Would you briefly explain what is meant by Creutzfeldt-Jakob disease?

Response: Creutzfeldt-Jakob disease (CJD) is an incurable—and ultimately fatal—transmissible, neurodegenerative disorder in the family of prion diseases. Prion diseases can be found in many mammalian species and are due to the conversion of normally harmless prion protein molecules into abnormally folded, aggregated and self-propagating clusters and filaments in the brain. The accumulation of these clusters has been associated with tissue damage that often leaves dying neurons and microscopic sponge-like holes in the brain. In the sporadic and genetic forms of CJD this pathogenic process appears to arise spontaneously in the patient.

However, the transfer of the prion protein aggregates from a Creutzfeldt-Jakob disease patient into another human or experimental animal can initiate the pathogenic process in the recipient. These infectious forms of prion protein are called prions. Human prion diseases include fatal insomnia; kuru; Gerstmann-Straussler-Scheinker syndrome; and variant, familial and sporadic CJD. Sporadic CJD is the most common human prion disease, affecting about one in one million people annually worldwide. Other prion diseases include scrapie in sheep; chronic wasting disease in deer, elk and moose; and bovine spongiform encephalopathy (BSE), or mad cow disease, in cattle.

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Adherence to HIV Treatment May Protect Brain From Further Injury

MedicalResearch.com Interview with:

Ryan Sanford

Ryan Sanford

Ryan Sanford, MEng
Department of Neurology and Neurosurgery
Montreal Neurological Institute
McGill University, Montréal, Québec, Canada
 

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

Response: With the introduction of combination antiretroviral therapy (cART) the outlook for HIV+ individuals has dramatically shifted from a fatal disease to a chronic manageable condition. However, HIV-associated neurocognitive disorders are still prevalent. The etiology of this dysfunction remains unknown. Previous work has reported progressive brain atrophy in HIV+ individuals with advanced disease and poor viral suppression, but it is unclear whether stable treatment and effective viral suppression can mitigate the progression of brain atrophy. To examine this issue, we followed well-treated HIV+ individuals with good viral suppression and well-matched controls, and assessed whether ongoing brain atrophy occurs over time.

The main finding in this study was the HIV+ participants had reduced brain volumes and poorer cognitive performance compared to the control group, but the changes in brain volumes and cognitive performance were similar between the groups.

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HIV PreExposure Prophylaxis -PrEP- For MSM Found To Be Effective and Cost Saving

MedicalResearch.com Interview with:

Dr Valentina Cambiano PhD Institute for Global Health University College London London UK

Dr. Cambiano

Dr Valentina Cambiano PhD
Institute for Global Health
University College London
London UK

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

Response: Pre-Exposure Prophylaxis (PrEP) which involves the use of drugs, which are used to treat HIV, in people without HIV to prevent them from getting is a critical new advance in HIV prevention. It has been shown to reduce the risk of HIV infection by 86% and the benefits heavily out-weigh any concerns. However, introducing this intervention has a cost.

When we started working on this study the National Health Services was discussing whether to introduce PrEP and if so for which populations. Unfortunately, at the moment NHS England is not providing Pre-exposure prophylaxis. However, a large study, the PrEP impact trial, funded by the NHS, has just started and this will provide PrEP to 10,000 people.

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Urban Transgender Females Likely To Get HIV Testing

MedicalResearch.com Interview with:

Adrian Juarez, PhD, RN Assistant Professor The State University of New York School of Nursing  Department of Family, Community and Health Systems Sciences Buffalo, New York 14214

Dr. Juarez

Adrian Juarez, PhD, RN
Assistant Professor
The State University of New York
School of Nursing
Department of Family, Community and Health Systems Sciences
Buffalo, New York 14214

 

 

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

Response: HIV testing is considered the initial component of HIV eradication strategies such as “seek, test, treat, and retain.” This study examines the characteristics of an urban, transgender population in western New York when volunteering for an HIV test. The use of an intersectional lens was observed in order to determine the level of influence of sexual partnership types, previous HIV and STD testing, substance use, housing status referral source and racial/gender identification on HIV testing.

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Toxin-Producing Bacteria Staph Aureus Induces Skin Inflammation

MedicalResearch.com Interview with:

Lloyd S. Miller, M.D., Ph.D. Vice Chair for Research, Department of Dermatology Associate Professor of Dermatology, Infectious Diseases, Orthopaedic Surgery & Materials Science and Engineering Faculty Member, Cellular and Molecular Medicine (CMM) and Pathobiology Graduate Programs Johns Hopkins Department of Dermatology Baltimore, MD 21231

Dr. Miller

Lloyd S. Miller, M.D., Ph.D.
Vice Chair for Research, Department of Dermatology
Associate Professor of Dermatology, Infectious Diseases, Orthopaedic Surgery & Materials Science and Engineering
Faculty Member, Cellular and Molecular Medicine (CMM) and Pathobiology Graduate Programs
Johns Hopkins Department of Dermatology
Baltimore, MD 21231 

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

Response: Staphylococcus aureus is a common bacterial skin pathogen and its abundance is greatly increased on affected skin of eczema patients, especially during disease flares. However, how S. aureus induces skin inflammation and exacerbates the skin inflammation is incompletely understood.

In this study, we found that S. aureus exposure of mouse skin induced skin inflammation through an inflammatory mediator known as IL-36.

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Even Treated, HIV-Positive Children Have Ongoing White Matter Brain Damage

MedicalResearch.com Interview with:
Marcin Jankiewicz  University of Cape Town Cape Town, South Africa
Marcin Jankiewicz 
University of Cape Town
Cape Town, South Africa 

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

Response: The Children with HIV Early Antiretroviral (CHER) trial, conducted in Cape Town and Soweto, was designed when there was uncertainty whether to start antiretroviral therapy (ART) as soon as HIV was diagnosed (below 12 weeks of age) or to wait until there was evidence of immuno-compromise and disease progression. Also, there were concerns about maintaining adherence, long-term toxicity and also resistance in the setting of few antiretroviral options. Early outcomes showed a decreased risk in childhood mortality in the early treatment arms compared to deferred treatment, becoming standard of care globally.

The CHER cohort is one of the largest and best documented of children receiving ART within the first year of life. Also, age- and community-matched HIV exposed uninfected (HEU) and HIV unexposed (HU) uninfected infants were enrolled in parallel for a linked vaccine study.

We therefore had an amazing opportunity to link with a neurodevelopmental sub-study in participants from Cape Town and apply sophisticated neuroimaging modalities that could link with clinical, virological and immunological characteristics.

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Marijuana Use Linked To Cognitive Impairment In HIV Patients

MedicalResearch.com Interview with:

Richard Saitz, MD, MPH, FACP, DFASAM Department of Community Health Sciences Boston University School of Public Health Clinical Addiction Research and Education (CARE) Unit Section of General Internal Medicine, Department of Medicin Boston University School of Medicine and Boston Medical Center Boston , Massachusetts

Dr. Saitz

Richard Saitz, MD, MPH, FACP, DFASAM
Department of Community Health Sciences
Boston University School of Public Health
Clinical Addiction Research and Education (CARE) Unit
Section of General Internal Medicine, Department of Medicin
Boston University School of Medicine and Boston Medical Center
Boston , Massachusetts

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

Response: Many people living with HIV infection use alcohol and other drugs including marijuana. People with HIV infection are also susceptible to cognitive dysfunction from many causes from HIV infection itself to aging.

The main findings were that among people with HIV and substance use disorder, lifetime marijuana and alcohol use were not associated with cognitive dysfunction, likely due to competing risks.  But current marijuana use was associated with cognitive dysfunction.

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Defective Viral Genomes May Indicate Greater Flu Virus Severity

MedicalResearch.com Interview with:
Ana Falcón
Department of Molecular and Cellular Biology
National Center for Biotechnology
Spanish National Research Council (CNB-CSIC)
Madrid, Spain

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

Response: Influenza A virus (IAV) infection can be severe or even lethal in toddlers, the elderly and patients with certain medical conditions. Infection of apparently healthy individuals nonetheless accounts for many severe disease cases and deaths, suggesting that viruses with increased pathogenicity co-circulate with pandemic or epidemic viruses.

IAV virulence and pathogenesis are dependent on complex, multigenic mechanisms involving the viral genetic characteristics, the host conditions, the virus-host interactions, and the host response to the infection. Influenza virus pathogenicity has been studied in depth for many years, and several amino acid changes have been identified as virulence determinants, however, a general pathogenicity determinant has not been characterized.

A proportion of influenza virus particles have defective genome RNAs (Defective Viral Genomes-DVGs) due to internal deletions of viral segments. The DVGs have the 3’ and 5’ ends of the parental RNA segments, and most have a single, large central deletion that generates viral RNAs of 180–1000 nucleotides. The presence of DVGs potentiates the host response in cultured cells and in animal models and leads to attenuated infection, possibly through recognition of double-stranded RNA by receptors that activate antiviral signaling cascades.

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Hospital Onset Clostridium difficile Infections Increased With Electronic Sepsis Alerts

MedicalResearch.com Interview with:

Dr. Robert Hiensch MD Assistant Professor, Medicine, Pulmonary, Critical Care and Sleep Medicine Icahn School of Medicine at Mount Sinai

Dr. Hiensch

Dr. Robert Hiensch MD
Assistant Professor, Medicine, Pulmonary, Critical Care and Sleep Medicine
Icahn School of Medicine at Mount Sinai.

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

Response: New sepsis guidelines that recommend screening and early treatment for sepsis cases appear to have significant positive impacts on patient outcomes. Less research has been published on what potential side effects may result from these guidelines.

Antibiotics are a cornerstone of sepsis treatment and early antibiotic administration is strongly recommended.  We examined whether the introduction of an electronic based sepsis initiative changed antibiotic prescribing patterns at our hospital. Antibiotics, even when appropriate, contribute to hospital onset Clostridium difficile infections (HO CDIs).  While the authors do not dispute the importance of antibiotic administration in sepsis, it is valuable to know whether the sepsis initiative coincided with both increased antibiotic administration and HO CDIs.

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More Evidence for Zika as a Causal Agent Of Guillain-Barré Syndrome

MedicalResearch.com Interview with:

Emilio Dirlikov, PhD Epidemic Intelligence Service Officer CDC 

Dr. Dirlikov

Emilio Dirlikov, PhD
Epidemic Intelligence Service Officer
CDC 

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

Response: In December 2015, Puerto Rico Department of Health (PRDH) reported its first confirmed locally acquired case of Zika virus disease. In February 2016, PRDH reported the first person diagnosed with Guillain-Barré syndrome (GBS) who also had evidence of Zika virus infection. At the time, scientific evidence of the potential association between Zika virus infection and GBS was lacking, and rigorous studies were needed.

Through a collaboration between PRDH, CDC, and the University of Puerto Rico (UPR), we conducted a case-control study to determine risk factors for GBS during the 2016 Zika virus epidemic. By prospectively enrolling case-patients, we shortened the time to enrollment, increasing the likelihood of detecting Zika virus nucleic acids to confirm Zika virus infection.

As a result, we found that an acute Zika virus infection confirmed by laboratory testing is a risk factor for developing Guillain-Barré syndrome. This is the first case-control study to find laboratory evidence showing this given the difficulty of confirming Zika virus infection among people diagnosed with GBS.

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Antibiotic-Resistant Organisms Affect Majority of Long-Term Care Patients

MedicalResearch.com Interview with:
Susan S. Huang, MD
Professor, Infectious Disease
School of Medicine
Medical Director, Epidemiology and Infection Prevention
UCI

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

Response:  The SHIELD Orange County Project is a CDC-initiated public health collaborative among nursing homes, long-term acute care (LTAC) facilities, and hospitals in the 6th largest U.S. County (Orange County, California). The 38 facilities (18 nursing homes, 3 LTACs, 17 hospitals) received targeted invitations based upon their high degree of shared patients with one another. The goal of the collaborative is to reduce multi-drug resistant organisms throughout the county using a decolonization strategy.

As part of the baseline assessment, we swabbed 50 adult patients in each facility to assess the frequency that patients had multi-drug resistant organisms (MDRO) on their body. Nursing home and LTAC patients were sampled from the entire population while hospital sampling involved only adults in contact precautions. We found that an alarmingly high percent of patients had an MDRO, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), extended-spectrum beta-lactamase producers (ESBLs), and carbapenem-resistant enterobacteriaceae (CRE).

  • For nursing homes, 64% of residents have an antibiotic resistant bacteria on their body. Almost all of these are not known to the nursing home.
  • For LTACs, 80% of patients have an antibiotic resistant bacteria on their body. 7 in 10 patients have an MDRO that is not known to the LTAC.
  • For hospitalized patients on contact precautions, 64% have an antibiotic-resistant bacteria on their body. One third have an antibiotic-resistant bacteria that is not known to the hospital.
  • Having one MDRO is highly associated with having another one/

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CMV Infections Increase Complications and Costs After Stem Cell Transplantation

MedicalResearch.com Interview with:

Dr. Jonathan Schelfhout, PhD Director, Outcomes Research Merck & Co. Inc. North Wales, PA

Dr. Schelfhout

Dr. Jonathan Schelfhout, PhD
Director, Outcomes Research
Merck & Co. Inc.
North Wales, PA

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

Response: The cost of hematopoietic stem cell transplantation has received increased attention after it was identified as a top 10 contributor to increasing healthcare costs in an AHRQ 2016 report. Many recent studies have explored the cost of HSCT but additional research is needed on the costly complications that can follow the transplant procedure. This research is particularly relevant for inpatient decision makers, as most transplant centers receive one bundled payment for the transplant and the treatment of any complications over the first 100 days.

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Antibiotics Prescribed By Dentists May Contribute To C.diff Infections

MedicalResearch.com Interview with:

Stacy Holzbauer, DVM, MPH, DACVPM CDC Career Epidemiology Field Officer (CEFO) Commander, USPHS Minnesota Department of Health St. Paul, MN

Dr. Holzbauer

Stacy Holzbauer, DVM, MPH, DACVPM
CDC Career Epidemiology Field Officer (CEFO)
Commander, USPHS
Minnesota Department of Health
St. Paul, MN

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

  • Antibiotics are not harmless drugs—Clostridium difficile infection, which can sometimes cause a deadly diarrhea, is a complication of antibiotic use and can occur after even one dose of an antibiotic.
  • The Minnesota Department of Health (MDH) is part of the larger Centers for Disease Control and Prevention (CDC) Emerging Infections Program (EIP). The healthcare-associated infection component of CDC’s EIP engages a network of state health departments and their academic medical center partners to help answer critical questions about emerging HAI threats including Clostridium difficile also known as “C. diff.”
  • In Minnesota, the majority of C. diff infections occur outside the hospital and are driven by antibiotic use in community or outpatient settings. In addition to routine surveillance data, we interview patients with C. diff who were not hospitalized prior to their infection to identify potential risks for developing C. diff infection, including identifying antibiotics received outside of routine healthcare settings.
  • Dentists prescribe approximately 10% of the antibiotics in outpatient settings, which was over 24 million prescriptions in 2013. When asked about their prescribing practices in a 2015 survey with the Minnesota Dental Association, 36% of dentists surveyed prescribed antibiotics for dental conditions that are generally not recommended to receive antibiotics according to American Dental Association (ADA) guidelines.

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Data From NY City Suggest PReP Use Is Increasing

MedicalResearch.com Interview with:
Paul M. Salcuni, MPH

Department of Health and Mental Hygiene
New York City

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

Response: NYC Health Department is committed to ensuring equitable access to HIV pre-exposure prophylaxis (PrEP) for all New Yorkers who are HIV-negative and may be exposed to HIV. We examined trends in PrEP prescribing by 602 ambulatory care practices in New York City from 2014 to 2016, as well as associated patient and practice factors, to inform our comprehensive scale-up efforts. For every 100,000 medical visits in the first three months of 2014, roughly 39 involved a patient being prescribed PrEP. In the second quarter of 2016, 419 of every 100,000 medical visits at those same practices involved a PrEP prescription.

Despite this nine-fold increase overall, some groups of patients among these practices were less likely to be prescribed PrEP. Those groups include men of color, women, and people getting health care at smaller private practices or practices outside of the city center.

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How Do Viruses Trigger Cough In Asthmatic Children, Even Without Allergies

MedicalResearch.com Interview with:

Giovanni Piedimonte, MD Steven and Nancy Calabrese Endowed Chair for Excellence in Pediatric Care, Research, and Education Professor & Chair of Pediatrics Cleveland Clinic Lerner College of Medicine Case Western Reserve University

Dr. Piedimonte

Giovanni Piedimonte, MD
Steven and Nancy Calabrese Endowed Chair for Excellence in Pediatric Care, Research, and Education
Professor & Chair of Pediatrics
Cleveland Clinic Lerner College of Medicine
Case Western Reserve University

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

Response: This study proves that asthmatic children already have a hyperactive calcium channel that’s extremely sensitive to environmental triggers.

If these children contract a virus, such as RSV, the hyperactive channel causes more severe symptoms that may require care in a hospital setting.

When a child developed asthma or bronchitis in the past, doctors thought these conditions could only be triggered by environmental allergens. There was no explanation why two out of three children ages five and under who wheeze and cough – and still test negative for allergies.

We needed to explore the mechanisms of the calcium molecule and the epithelial cells, which seem to trigger these symptoms without an allergic reaction. If the molecule’s behavior is producing the cough, we just need to figure out how to control the molecule to properly deactivate the cough mechanism in the asthmatic child

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MRSA Contamination of Home and Pets May Contribute To Reinfection and Resistance

MedicalResearch.com Interview with:

Mr-Jonathan-Shahbazian

Mr. Shahbazian

Mr. Jonathan Shahbazian, MPH
Johns Hopkins Bloomberg School of Public Health
Baltimore

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

Response: Our study was designed to investigate risk factors for drug resistance in MRSA found in dust on surfaces in the home. We undertook this investigation because we were concerned first that people living in the home could pick up MRSA from these surfaces, and second, that if they picked up drug-resistant MRSA, it would be more difficult to treat them.

Our main finding was that use of antibiotics by either people or pets in the home, as well as use of biocidal cleaning products, was associated with multidrug resistance (MDR) in home MRSA. This study is the first to report that use clindamycin in either humans or domestic animals was not associated with risk of MDR in the home environment.

We also found that mupirocin treatment was associated with a slight increase in mupirocin resistance in the household environment, which could complicate decolonization efforts that rely on use of nasal mupirocin ointment. We found that 100% of our MRSA isolates from rural homes were MDR, suggesting living in a rural household may be a risk factor. We also found the presence of domestic pets was associated with MDR MRSA in the home environment while the presence of unwanted pests, such as mice or cockroaches, was associated with non-MDR MRSA strains at the three-month visit.

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TDAP Vaccine During Pregnancy Prevents Whooping Cough In Young Babies

MedicalResearch.com Interview with:
Tami H Skoff Centers for Disease Control and Prevention Atlanta, Georgia
Tami H Skoff
Centers for Disease Control and Prevention
Atlanta, Georgia

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

Response: Infants are at greatest risk for severe pertussis (whooping cough) morbidity and mortality, especially during the first months of life before infant immunizations begin.  CDC and the Advisory Committee on Immunization Practices (ACIP) currently recommend that women receive a dose of Tdap during the third trimester of each pregnancy.  This recommendation has been in place since 2012.  By getting Tdap, pregnant women pass critical short-term protection to their unborn babies. This helps protect babies until they are old enough to start getting their own whooping cough vaccines at 2 months of age.

The purpose of our study was to evaluate the effectiveness of maternal Tdap during pregnancy at preventing whooping cough in infants <2 months of age.

In our evaluation, Tdap administration during the third trimester of pregnancy prevented more than 3 in 4 (78%) infant cases.  Additionally, Tdap vaccination during pregnancy was even more effective (90%) at preventing whooping cough serious enough that the baby had to get treatment in a hospital.

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Parasitic Infection With Toxoplasmosis May Be Linked To Parkinson’s & Alzheimer’s Disease

MedicalResearch.com Interview with:

Under a magnification of 900X, this hematoxylin and eosin-stained (H&E) photomicrograph of a brain tissue specimen revealed a case of neurotoxoplasmosis in a patient who had also been diagnosed with multiple myeloma. Note the Toxoplasma gondii tissue cyst, within which bradyzoites could be seen developing. CDC Image

Rima McLeod, M.D., F.A.C.P, F.I.D.S.A
Professor of Ophthalmology and Visual Sciences,Pediatrics (Infectious Diseases), and The College,
Director, Toxoplasmosis Center,
Senior Fellow,Institute of Genomics, Genetics and Systems Biology, Member, Commitees on Immunology, and Molecular Medicine and Pathogenesis,
Member Global Health Center, Affiliate CHeSS;
Attending Physician, Chicago Medicine,
The University of Chicago

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

* One third of humans are infected lifelong with the brain-dwelling, protozoan parasite, Toxoplasma gondii.
* Approximately fifteen million of these have congenital toxoplasmosis.
* The parasite interconverts between slow-growing, encysted bradyzoites and rapid-growing tachyzoites.
* In mice, T. gondii creates a chronic intra-neuronal infection and an inflammatory process.
* Mice with acute and chronic infection have alterations in neurotransmitters, memory, seizures, and neurobehavior.
* Some epidemiologic-serologic studies show associations between seropositivity for T. gondii and human neurologic diseases, for example, Parkinson’s and Alzheimer’s diseases.
* Although neurobehavioral disease is associated with seropositivity, causality is unproven.
* Serologic studies of humans with diverse genetics are not optimal to detect strong associations or directionality.
* Epidemiologic associations also do not reveal parasite-modulated gene networks in human brain that could provide insights into how to cure and prevent resultant diseases.
* We need integrative approaches to examine relationships between brain parasitism and other brain diseases, to provide a foundation to identify key pathways and molecules for drug and vaccine design
* To address these problems, we considered two central questions: (i) If chronic brain parasitism associates with other neurologic diseases, what are they? And (ii) Which macromolecular networks are modulated by the parasite in human brain that lead to neuropathology which could underpin and facilitate design of treatments?
* We hypothesized that a systems approach integrating multiple levels of host parasite interactions might resolve these questions.
* To better understand what this parasite does to human brains, we performed a comprehensive systems analysis of the infected brain.  Continue reading

48-Hours of Antibiotics Reduced Infection Rate After C-Section in Obese Women

MedicalResearch.com Interview with:

Dr. Carri R. Warshak, MD Associate Professor of Obstetrics & Gynecology University of  Cincinnati

Dr. Warshak

Dr. Carri R. Warshak, MD
Associate Professor of Obstetrics & Gynecology
University of  Cincinnati

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

Response: Cesarean deliveries are the most common major surgical procedure performed in the United States.  A common complication of cesarean section is wound infections that can include infections in the skin and incision site, or infections in the uterus itself after delivery.  These complications can lead to prolonged hospitalization after delivery for antibiotics and even further surgery in severe infections.  Often these wound complications lead to delayed healing, wound opening which can sometimes take several weeks to heal. Studies have demonstrated as many as 12% of women experience a surgical site infection after delivery.

Obesity is a strong risk factor for increased surgical site infections.  Increasing maternal weight increases the risk of wound complications, with a two to five fold increase in risk, making surgical site infections and common and concerning complication of cesarean delivery in obese women.

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New Assay Can Distinguish Between Viral and Bacterial Infections in Kids

MedicalResearch.com Interview with:
Prof. Alain Gervaix
Head of the Emergency Division
Department of Children and Adolescents
University Hospitals of Geneva
Switzerland

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

Response: Many are familiar with the following ‘seemingly’ simple clinical dilemma that occurs on a daily basis across the world. A patient visits the doctor with a fever. Commonly, assigning a diagnosis comes down to deciding whether the infection is bacterial or viral. Accordingly, the doctor decides if to treat or not to treat with antibiotics. The problem is that bacterial and viral infections often present with very similar symptoms, causing uncertainty that leads to antibiotics being used, in many instances, when they are not needed. This antibiotic misuse contributes to the rise of antimicrobial resistance, one of the biggest health threats of the 21st century.

Host biomarkers hold great promise as routine diagnostic tools that can assist doctors in making correct antibiotic treatment decisions, as they overcome key limitations of currently applied pathogen-based tests. Recently, a novel host-assay (ImmunoXpert™) for differentiating bacterial from viral infections was developed and validated to yield high sensitivity and specificity. The three-protein host-assay comprises tumor necrosis factor-related apoptosis-inducing ligand (TRAIL), Interferon gamma-induced protein-10 (IP-10) and C-reactive protein (CRP).

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Pandemic Flu May Increase Risk of Type 1 Diabetes In Genetically Predisposed Patients

MedicalResearch.com Interview with:
Paz Lopez-Doriga Ruiz MD, PhD candidate Norwegian Institute of Public Health Department of Non Communicable Diseases OsloPaz Lopez-Doriga Ruiz MD, PhD candidate

Norwegian Institute of Public Health
Department of Non Communicable Diseases
Oslo 

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

Response: Some case reports have linked pandemic influenza to the development of type 1 diabetes. Other studies have suggested that also respiratory infections may contribute to type 1 diabetes risk.

 Our findings supports a suggested role of respiratory infections in the etiology of type 1 diabetes and influenza virus could be a contributing factor to the development of clinical diabetes, due to stress and inflammation in predisposed individuals.

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Incidence of Sepsis Stable, But Mortality Remains High

MedicalResearch.com Interview with:

Dr. Chanu Rhee MD, Assistant Professor Therapeutics Research and Infectious Disease Epidemiology Group Department of Population Medicine at Harvard Medical School / Harvard Pilgrim Health Care Institute Critical Care and Infectious Disease Physician Transplant/Oncology Infectious Disease service and Medical Intensive Care Unit at Brigham and Women’s Hospital

Dr. Rhee

Dr. Chanu Rhee MD, Assistant Professor
Therapeutics Research and Infectious Disease Epidemiology Group
Department of Population Medicine at Harvard Medical School / Harvard Pilgrim Health Care Institute
Critical Care and Infectious Disease Physician
Transplant/Oncology Infectious Disease service and
Medical Intensive Care Unit at Brigham and Women’s Hospital 


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

Response: Multiple studies suggest that the incidence of sepsis, the syndrome of life-threatening organ dysfunction caused by infection, is increasing over time, while mortality rates are decreasing.  However, reliably measuring sepsis incidence and trends is challenging because clinical diagnoses of sepsis are subjective and insurance claims data, the traditional method of surveillance, can be affected by changing diagnosis and coding practices over time.

In this study, my colleagues and I estimated the current U.S. burden of sepsis and trends using clinical data from the electronic health record systems of a large number of diverse hospitals. The findings, published in JAMA, challenge the use of claims data for sepsis surveillance and suggest that clinical surveillance using electronic health record data provides more objective estimates of sepsis incidence and outcomes.

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New Test for TB Can Detect Antibiotic Resistant Strains

MedicalResearch.com Interview with:

Susan E. Dorman, M.D Associate Professor of Medicine, Division of Infectious Diseases Johns Hopkins University School of Medicine, Baltimore

Dr. Dorman

Susan E. Dorman, M.D
Associate Professor of Medicine, Division of Infectious Diseases
Johns Hopkins University School of Medicine, Baltimore

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

Response: Tuberculosis, also called “TB” is one of the top 10 causes of death worldwide, according to the World Health Organization.  TB is caused by bacteria called Mycobacterium tuberculosis.  In 2015, over 10 million people became sick from TB and 1.8 million people died from TB.  This is a lot of people – diagnosing and treating TB to improve their health is important.  Because TB usually involves the lungs, it can be passed from person to person through the air, and thus, diagnosing and treating TB is critical to  reduce the spread of TB.   Drug-resistant TB — TB caused by bacteria that are resistant to commonly used TB antibiotics — is a serious problem.  In 2015 an estimated 480,000 people had multidrug-resistant TB.

We have been working to develop better, faster ways to diagnose TB and drug-resistant TB.  A new test was developed as a partnership between Rutgers University and Cepheid (Sunnyvale, CA), and development was supported by the US National Institutes of Health (NIH).  The new test was designed to detect Mycobacterium tuberculosis bacteria in sputum, and to simultaneously detect whether the bacteria are resistant to several of the main antibiotics (isoniazid, fluoroquinolones, and aminoglycosides) used to treat TB.  The test takes about two hours from sample to result.

The NEJM article describes the results of a study that was undertaken in China and South Korea to understand how well the new test works, compared against gold standard tests.

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New Rapid Flu Tests Are Simple, Fast and Accurate

MedicalResearch.com Interview with:

Jesse Papenburg, MD MSc FRCPC FRQS Clinical Research Scholar Assistant Professor of Pediatrics, McGill University Div. of Pediatric Infectious Diseases, Dept. of Microbiology Montreal Children’s Hospital Montreal, QC

Dr. Papenburg

Jesse Papenburg, MD MSc FRCPC
FRQS Clinical Research Scholar
Assistant Professor of Pediatrics, McGill University
Div. of Pediatric Infectious Diseases, Dept. of Microbiology
Montreal Children’s Hospital
Montreal, QC 

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

Response: Influenza viruses cause yearly epidemics of acute respiratory illness affecting 5 to 30 percent of the population. Diagnosing influenza on the basis of only clinical symptoms is difficult because its manifestations vary and are nonspecific. Reverse transcriptase polymerase chain reaction (RT-PCR) is the gold standard for flu diagnosis, but these tests must be sent to a laboratory and have turnaround times that extend beyond the clinical encounter. Rapid and accurate diagnosis of influenza has the potential to improve patient outcomes and decrease health care costs.

Since 2011, two novel classes of rapid influenza diagnostic assays i.e., with results available in <30 minutes, have been commercialized with claims of improved sensitivities based on technological improvements: 1) automated immunochromatographic antigen detection tests (digital immunoassays, DIAs) and 2) rapid nucleic acid amplification tests (NAATs).

Our systematic review and meta-analysis synthesized the available evidence and compared the diagnostic accuracy of commercially available rapid tests for the detection of influenza A and B infection:

  • Overall, the rapid tests displayed very high specificities (≥98%). Physicians can therefore diagnose influenza with confidence on the basis of a positive RIDT, DIA, or rapid NAAT result.
  • The pooled sensitivities for DIAs (80.0% for influenza A and 76.8% for influenza B) and rapid NAATs (91.6% for influenza A and 95.4% for influenza B) are markedly higher than those for RIDTs (54.4% for influenza A and 53.2% for influenza B).

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Third Dose of MMR Vaccine Reduced Risk of Mumps in University Students

MedicalResearch.com Interview with:

Cristina V. Cardemil, M.D., M.P.H. Pediatrics, Primary Care, Public Health Centers for Disease Control and Prevention Atlanta, GA 30333

Dr. Cardemil

Cristina V. Cardemil, M.D., M.P.H.
Pediatrics, Primary Care, Public Health
Centers for Disease Control and Prevention
Atlanta, GA 30333 

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

Response: The effect of a third dose of the measles–mumps–rubella (MMR) vaccine in stemming a mumps outbreak is unknown. During an outbreak among vaccinated students at the University of Iowa, health officials implemented a widespread MMR vaccine campaign. We evaluated the effectiveness of a third dose of MMR vaccine in preventing mumps cases during the outbreak, and assessed for waning immunity.

Of 20,496 university students enrolled in the 2015-16 academic year, 259 developed mumps. Prior to the outbreak, 98.1% of students had received two or more doses of MMR vaccine. During the outbreak, 4,783 students received a third dose.

The attack rate was lower among students who received a third dose of MMR vs. 2-dose recipients (6.7 vs. 14.5 per 1,000, respectively). Students had at least nine times greater risk of getting mumps if they received their second dose of MMR 13 years or more prior to the outbreak. Individuals who received a third MMR vaccine dose had a 78% lower risk for mumps than individuals who had received only two doses. This study demonstrates a lower risk of mumps in 3-dose MMR vaccine recipients, suggesting the MMR vaccine dose campaign prevented cases and may have helped stop the spread of the outbreak. Waning immunity likely contributed to the spread of the outbreak.

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Can Zika Be Used To Fight Glioblastoma Brain Tumors?

MedicalResearch.com Interview with:

Milan G. Chheda, MD Assistant Professor  Department of Medicine  Oncology Division  Molecular Oncology  Department of Neurology Washington University School of Medicine in St. Louis

Dr. Chheda

Milan G. Chheda, MD
Assistant Professor
Department of Medicine
Oncology Division
Molecular Oncology
Department of Neurology
Washington University School of Medicine in St. Louis

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

Response: Glioblastoma is an extremely aggressive brain tumor. Most patients die in less than two years. A longstanding challenge has been killing tumor cells that are inherently resistant to our current therapies (radiation and chemotherapy). These cells, called cancer stem cells, are extremely hardy. A longstanding dream of oncologists has been to devise a way to find them and kill them. The public health epidemic in 2015 made Zhe Zhu, post-doctoral fellow in Jeremy Rich’s lab, wonder whether Zika virus could work on cancer stem cells, that share properties with stem cells in fetal brain. Zika virus doesn’t cause significant problems in adults.

We took a lesson from nature and tested Zika virus.

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Public Has Negative View Of Genetically Modified Mosquitoes

MedicalResearch.com Interview with:

Cinnamon S. Bloss, Ph.D. Associate Professor, Department of Psychiatry Department of Family Medicine and Public Health, Division of Health Policy University of California, San Diego

Dr. Bloss

Cinnamon S. Bloss, Ph.D.
Associate Professor, Department of Psychiatry
Department of Family Medicine and Public Health
Division of Health Policy
University of California, San Diego

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

Response: In 2016, the FDA invited public comments on a draft environmental assessment for a proposed field trial of a genetically modified (GM) mosquito designed to suppress wild-type Aedes aegypti mosquitoes. The preliminary finding from the environmental assessment indicated the trial would be unlikely to adversely affect the environment in Key Haven, Florida, the proposed trial site. We assessed public response to this trial based on the content of public comments submitted to the FDA by requesting comment transcripts through the Freedom of Information Act.

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Low Risk of Pneumocystis Pneumonia in Autoimmune Blistering Diseases

MedicalResearch.com Interview with:

Kyle T. Amber, MD Department of Dermatology UC Irvine Health  Irvine, CA 92697

Dr. Amber

Kyle T. Amber, MD
Department of Dermatology
UC Irvine Health
Irvine, CA 92697 

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

Response: Patients with autoimmune blistering diseases often requires significant immunosuppression in order to control their diseases. Pneumocystis pneumonia is an opportunistic infection that occurs in immunocompromised patients.  This study was borne out of my observation that most European experts in the treatment of autoimmune blistering disease did not give routine prophylaxis for pneumocystis. Among American dermatologists, there was far more disagreement. This was a collaborative effort of several international tertiary care centers. We demonstrated that the incidence of pneumocystis in 801 patients with autoimmune blistering disease was only 0.1%, which fell well below previous recommendations in the literature suggesting an incidence of 3.5% in order to justify prophylaxis.

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In the Age of Antiretrovirals for HIV, New Secondary Tumors Have Emerged

MedicalResearch.com Interview with:

Fahad Mukhtar MD MPH Department of Epidemiology and Biostatistics College of Public Health University of South Florida, Tampa

Dr. Mukhtar

Fahad Mukhtar MD MPH
Department of Epidemiology and Biostatistics
College of Public Health
University of South Florida, Tampa

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

Response: Studies done in the 80s and 90s showed that patients with Kaposi sarcoma may be at risk of having secondary tumors. As a result of changes that have taken place in the demographics of patients affected with HIV/AIDS as well as Kaposi’s sarcoma, we hypothesized that tumors that follow Kaposi sarcoma might have also changed. We analyzed the incidence of second tumors developing after Kaposi sarcoma using the Surveillance Epidemiology and End Result (SEER) data.

Our result indicated that the incidence of secondary tumors following Kaposi sarcoma have decreased after the emergence of antiretroviral therapy. However, we observed a significantly higher than expected number of cancer of the anus, liver, tongue, penis lymphomas, and acute lymphocytic leukemia developing in patients with Kaposi sarcoma in the era of antiretroviral therapy.

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Oropharyngeal Cancer Rising In Incidence and Costs to Over $140,000

MedicalResearch.com Interview with:

David R. Lairson, PhD Professor of Health Economics Division of Management Policy and Community Health Co-Director, Center for Health Services Research School of Public Health The University of Texas Health Science Center at Houston (UTHealth)

Dr. Lairson

David R. Lairson, PhD
Professor of health economics
Department of Management, Policy, and Community Health
The University of Texas Health Science Center at Houston (UTHealth) School of Public Health

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

Response: The study of oropharyngeal cancer treatment cost was initiated by the Head and Neck Cancer Surgery Department at the University of Texas MD Anderson Cancer Center as part of a larger study of the economic and health consequences of human papillomavirus (HPV) related conditions in Texas.  State specific information is required for policy-makers to consider future investments in cancer prevention based on HPV immunization and cancer screening.  The cost estimates at $140,000 per case for the first two years of treatment are substantially higher than previous estimates.  They indicate the potential savings associated with cancer prevention and partially justify increased investment in immunization efforts.

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H. pylori May Increase Risk of Stomach Cancer By Turning On Subset of Stem Cells

MedicalResearch.com Interview with:
Michael Sigal PhD

Clinical scientist of the Charité — Universitätsmedizin Berlin
Investigator at the Max Planck Institute for Infection Biology 

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

Response: We have previously found that H. pylori can colonize gastric glands and that in colonized glands the epithelial turnover was increased. We wanted to characterize the mechanisms that control the gland turnover in the stomach.

We found that Axin2, a classic Wnt target gene, marks two different subpopulations of cells with stem cell properties, one of which is Lgr5-positive and the other one Lgr5-negative. Both populations are affected by Rspondin 3, that is produced in myofibroblasts right beneath the stem cell compartment. Rspondin is crucial for stem cell signaling and knockout of Rspondin 3 in myofibroblasts results in loss of Lgr5 and Axin2 expression. Once we increased the bioavailability of Rspondin, that now could also interact with cells outside of the stem cell compartment, we noticed that the number of Axin2 positive stem cells dramatically increased. Of interest, only Lgr5-negative cells expanded in number and proliferate more, while the Lgr5-positive cells remained silenced.

Infection with Helicobacter pylori leads to an expansion of Axin2-positive cells which is driven by increased expression of Rspondin3. Expansion of the long lived stem cell pool could be an explanation for how H. pylori infection increases the risk for gastric cancer.

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Risky Behaviors Linked To Contact Lens–Related Eye Infections Among Adults and Adolescents

MedicalResearch.com Interview with:

Dr. Jennifer R. Cope MD Medical Officer Division of Foodborne, Waterborne, and Environmental Diseases National Center for Emerging and Zoonotic Infectious Diseases CDC

Dr. Cope

Dr. Jennifer R. Cope MD
Medical Officer
Division of Foodborne, Waterborne, and Environmental Diseases
National Center for Emerging and Zoonotic Infectious Diseases
CDC

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

Response: Wearing contact lenses can increase your chances of getting a severe eye infection. Eye infections can lead to serious problems, including blindness. All contact lens wearers can help prevent serious eye infections by correctly wearing and caring for their contact lenses.

Eighty-one percent of young adults, 85% of adolescents, and 88% of older adults regularly did at least one risky behavior related to their contact lenses. The most frequently reported risk behaviors in adolescents were not visiting an eye doctor as least annually, sleeping or napping in lenses, and swimming in lenses.

Among young adults and older adults, the most frequently reported risk behaviors were replacing lenses at intervals longer than those prescribed, replacing lens storage cases at intervals longer than those recommended, swimming in lenses, and sleeping or napping in lenses.

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Increase in HPV+ Oropharyngeal Cancers Suggests Both Sexes Should Be Vaccinated

MedicalResearch.com Interview with:

Steven Habbous MSc, PhD candidate Ontario Cancer Institute Scarborough, Ontario, Canada

Steven Habbous

Steven Habbous MSc, PhD candidate
Ontario Cancer Institute
Scarborough, Ontario, Canada

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

Response: Human papillomavirus (HPV) is a strong risk factor for oropharyngeal cancers (a subset of head and neck cancers). Because HPV-related oropharyngeal cancers generally respond well to treatment and may be prevented through HPV vaccination, it is critical to be able to accurately estimate the incidence and prevalence of this disease. Only recently, however, has testing for HPV become routine at most cancer centres across Canada.  As a result, attempts to estimate the growth of HPV-related oropharyngeal cancer over time may be inaccurate.

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Nasal Spray Flu Vaccine Ineffective and Not Recommended

MedicalResearch.com Interview with:

Michael Jackson  PhD, MPH Kaiser Permanente Washington Health Research Institute (KPWHRI) principal investigator for the United States Influenza Vaccine Effectiveness Network

Dr. Jackson

Michael Jackson  PhD, MPH
Kaiser Permanente Washington Health Research Institute (KPWHRI) principal investigator for the United States Influenza Vaccine Effectiveness Network 

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

  • Response: Each year, Kaiser Permanente Washington is one of five sites across the country that participate in the United States Influenza Vaccine Effectiveness Network. The Network reports its early interim results in the MMWRand presents additional interim results to the Advisory Committee on Immunization Practices (ACIP)This New England Journal of Medicine publication is an update of those interim results.
  • The findings in this New England Journal of Medicine are special because prior randomized controlled trials indicated that the nasal spray vaccine (FluMist)—also called live attenuated influenza vaccine (LAIV)—would work well to protect children and teens from the flu, whereas in actual practice we found that the flu shot worked much better, particularly against the predominant strain, A(H1N1)pdm09.
  • The nasal spray vaccine was first seen to be less effective for young children than the flu shot in 2013-2014 for the A(H1N1)pdm09 virus strain. In response, the A(H1N1)pdm09 virus strain used in the nasal spray vaccine was changed for the 2015-2016 influenza season. The 2016/17 season was the first since 2015-2016 to be dominated by the A(H1N1)pdm09 virus, making this our first opportunity to evaluate the updated nasal spray vaccine.
  • The Influenza Vaccine Effectiveness Network evaluated the impact of this change as part of our estimates of influenza vaccine effectiveness in 2015-2016. Preliminary findings from this study were presented to the ACIP in June 2016, which led to the nasal spray vaccine not being recommended in 2016-2017 in the US, although the nasal spray vaccine remains licensed in the US. In 2016-2017, the LAIV A(H1N1)pdm09 vaccine strain was unchanged from 2015-2016.

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Single Measurement May Underestimate HIV Viral Suppression

MedicalResearch.com Interview with:
Dr. Nicole Crepaz PhD
Behavioral Scientist
Division of HIV/AIDS Prevention
CDC

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

Response: The most common measure of viral suppression in clinical and surveillance studies is the most recent viral load in past 12 months. This single-value measure does not capture the viral load dynamics over time. We examined durable viral suppression, never virally suppressed, and cumulative HIV burden (measured in the viremia copy-year) to help us better understand viral suppression and transmission risk potential.

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Why Is HIV More Common in African American Women?

MedicalResearch.com Interview with:

Dr. Tiffany Aholou Behavioral Scientist Division of HIV/AIDS Prevention CDC

Dr. Aholou

Dr. Tiffany Aholou
Behavioral Scientist
Division of HIV/AIDS Prevention
CDC

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

Response: Women accounted for 24% of people living with HIV in the United States at the end of 2013 and 19% of HIV diagnoses in 2014. Of these diagnoses, 78% were among black women and Latinas. HIV diagnoses among women are overwhelmingly attributed to heterosexual contact with a person known to have, or to be at high risk for, HIV infection. Of note, new HIV diagnoses among US women declined 40% over a 10 year period (2005-2014), yet we continue to see significant racial/ethnic disparities due largely to a complex web of demographic, individual, social and contextual factors with the environment that enables HIV risk behaviors to occur.

While the decline in new HIV diagnoses among US women is noteworthy, in our review of the literature, we found research studies that specifically focus on women and HIV from a domestic perspective were scarce. To fill this gap and sharpen our understanding about sexual behaviors that are associated with heterosexual transmission of HIV, this study used data from three cycles of the National Survey of Family Growth (2006-2008, 2008-2010, and 2011-2013) to examine HIV-related sexual risk and protective behaviors – concurrent sex partnerships, non-monogamous sex partners, and condom use at either last vaginal sex  or anal sex  – among sexually active women aged 18-44 years by race/ethnicity and over time.

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Once-Daily, Fixed-Dose Combination Tablet Containing Doravirine Achieved HIV-1 Viral Suppression

MedicalResearch.com Interview with:

Dr. Kathleen Squires MD Professor and Director of Infectious Diseases Thomas Jefferson University Philadelphia, PA 

Dr. Squires

Dr. Kathleen Squires MD
Professor and Director of Infectious Diseases
Thomas Jefferson University
Philadelphia, PA 

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

  • The pivotal Phase 3 DRIVE-AHEAD study evaluated the safety and efficacy of a once-daily, single tablet, fixed-dose combination containing doravirine, an investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection, compared to a fixed-dose combination containing efavirenz.
    • After 48 weeks of treatment, 84 percent of the 364 treatment-naïve patients taking once-daily DOR/3TC/TDF achieved levels of HIV-1 RNA <50 copies/mL compared to 81 percent of the 364 patients taking once-daily EFV/FTC/TDF, with an estimated treatment difference of 3.5 percent.
    • Increases in mean CD4+ T-cell counts from baseline for the DOR/3TC/TDF and EFV/FTC/TDF groups were 198 and 188 cells/mm3, respectively, with an estimated treatment difference of 10.1.
    • In addition, comparable efficacy was observed across both treatment groups among individuals with high viral load (HIV-1 RNA >100,000 copies/mL) at baseline, which consisted of 69 patients in the DOR/3TC/TDF group and 73 patients in the EFV/FTC/TDF group (Observed Failure approach).
      • Of those patients with a high viral load (HIV-1 RNA >100,000 copies/mL) at baseline, 81 percent in the DOR/3TC/TDF group and 81 percent in the EFV/FTC/TDF group achieved the study’s primary endpoint of <50 copies/mL of HIV-1 RNA, with a treatment difference of 1.0 percent.
    • The study also met its primary safety endpoint, showing that treatment with DOR/3TC/TDF resulted in fewer patients reporting events of several pre-specified neuropsychiatric adverse events compared to EFV/FTC/TDF by Week 48, including dizziness (8.8 percent versus 37.1 percent); sleep disorders and disturbances (12.1 percent versus 25.5 percent); and inability to think clearly or concentrate (4.4 percent versus 8.2 percent).

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ONCEMRK Study: Once Daily Raltegravir In Combination With Other Antivirals Effective For Some HIV Patients

MedicalResearch.com Interview with:

Dr. Pedro Cahn Chief of the infectious disease unit at Juan A. Fernandez Hospital Buenos Aires, Argentina, and ONCEMRK lead study investigator

Dr. Pedro Cah

Dr. Pedro Cahn
Chief of the infectious disease unit at Juan A. Fernandez Hospital
Buenos Aires, Argentina, and
ONCEMRK lead study investigator

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

The ONCEMRK Phase 3 study was conducted to evaluate the efficacy and safety of once-daily ISENTRESS (raltegravir) HD 1200 mg (given as two 600 mg oral tablets) compared to twice daily raltegravir 400 mg, each in combination therapy with emtricitabine plus tenofovir disoproxil fumarate in previously untreated adults with HIV-1 infection with levels of HIV-1 RNA ≥ 1,000 copies/mL.

  • Week 96 data showed:
    • 5 percent of the 531 patients taking once-daily raltegravir 1200 mg (2 x 600 mg) achieved viral suppression of less than 40 copies/mL of HIV-1 RNA, compared to 80.1 percent of the 266 patients taking twice-daily raltegravir 400 mg, both in combination therapy with emtricitabine plus tenofovir disoproxil fumarate, with a treatment difference of 1.4 percent.
    • Increases in CD4+T-cell counts from baseline were comparable for the two treatment regimens, with an average increase of 261.6 cells/mm3 for once-daily raltegravir (1200 mg) and 262.2 cells/mm3 for twice-daily raltegravir (400 mg).
    • Efficacy was consistent across a variety of patient populations, including those with high viral load at baseline (HIV-1 RNA >100,000 copies/mL).
    • Treatment-emergent viral mutations leading to any drug resistance were detected in less than 1 percent of patients in both treatment arms, with 4/531 (0.8 percent) in the once-daily raltegravir (1200 mg) treatment arm, and 2/266 (0.8 percent) in the twice-daily raltegravir (400 mg) treatment arm through 96 weeks.
    • The rate of discontinuation of therapy due to adverse events through 96 weeks was low (1.3 percent in patients receiving once-daily raltegravir (1200 mg) and 2.3 percent in patients receiving twice-daily raltegravir (400 mg).

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High Dose Vitamin D No Advantage In Preventing Pediatric Viral Infections

MedicalResearch.com Interview with:

Jonathon Maguire MD MSc FRCPC Scientist, Li Ka Shing Knowledge Institute

Dr. Maguire

Jonathon Maguire MD MSc FRCPC
Scientist, Li Ka Shing Knowledge Institute
Staff Pediatrician, Department of Pediatrics, St. Michael’s Hospital

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

Response: Vitamin D has been hypothesized as being protective of seasonal viral upper respiratory tract infections.  In this randomized clinical trial, high dose wintertime vitamin D supplementation (2000 IU/day) was compared with standard-dose vitamin D supplementation (400 IU/day) among 703 children.  The number of laboratory confirmed viral upper respiratory tract infections was not statistically different between groups.

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Higher HIV Viral Loads Linked to Increased Squamous Cell Cancers of Skin

MedicalResearch.com Interview with:

Maryam M. Asgari, MD, MPH Department of Dermatology, Massachusetts General Hospital, Department of Population Medicine Harvard Medical School, Boston, Massachusetts Division of Research, Kaiser Permanente Northern California, Oakland

Dr. Asgari

Maryam M. Asgari, MD, MPH
Department of Dermatology
Massachusetts General Hospital,
Department of Population Medicine
Harvard Medical School, Boston, Massachusetts
Division of Research, Kaiser Permanente
Northern California, Oakland

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

Response: Nonmelanoma skin cancer – defined as basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) – is a common malignant condition, affecting more than 2 million Americans every year. BCCs are more common than SCCs among individuals with healthy immune systems, while SCCs are more predominate than BCCs among people who are immunocompromised.

We examined how laboratory markers used to evaluate HIV disease progression may be associated with subsequent nonmelanoma skin cancer risk in white patients previously diagnosed with at least one such cancer from 1996 to 2008.  We measured CD4 count, viral load and subsequent nonmelanoma skin cancer. The study included 455 participants with HIV and 1,952 without HIV. All were members of the Kaiser Permanente Northern California health care plan.

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Could Vaccine Against Meningococcus Help Protect Against Gonorrhea?

MedicalResearch.com Interview with:
Helen Petousis-Harris. BSc, PhD

Senior Lecturer, Dept General Practice and Primary Health Care
Academic Head, Immunisation Research and Vaccinology
Immunisation Advisory Centre
School of Population Health, Faculty of Medical and Health Sciences
University of Auckland

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

Response: Early thinking came from two quarters. One, the observation that the NZ OMV vaccine appeared broadly protective – beyond the clone it was based on and two, the observation of graphs depicting annual number of cases from both Cuba and NZ. There is nothing to suggest other types of meningococcal vaccine have had any effect on gonorrhoea so we are interested in the OMV vaccines. This led to the hypothesis that as these two Neisseria species are related the meningococcal OMV in the form of a vaccine may offer some kind of cross protection.

To explore this possibility we conducted a case-control study that compared the vaccination status of cases (gonorrhoea) and controls (Clamydia). We found that the cases with gonorrhoea were less likely to be vaccinated than the controls and after we controlled for confounders – ethnicity, SE deprivation, age we found a vaccine effectiveness of 31%.

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Dissolvable Microneedle Patches Can Be Vaccination Game Changer

MedicalResearch.com Interview with:
Dr Nadine G Rouphael MD
Associate Professor of Medicine, Emory University
Director of the VTEU and HIPC networks at the
Hope Clinic of the Emory Vaccine Center
Decatur GA 30030, USA

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

Response: Different groups including a group of researchers at Georgia Tech have been working on the microneedle technology for more than 20 years. The dissolvable microneedle patches are already used in several cosmetic products and drugs. However, vaccination with microneedle patches has been studied mostly in animals.

Our phase 1 trial published this week in The Lancet showed that vaccination with the microneedle patches was safe, with no related serious adverse events reported. Local skin reactions to the patches were mostly mild itching and faint redness that lasted two to three days. No new chronic medical illnesses or influenza-like illnesses were reported with either the patch or the injection groups. Antibody responses generated by the vaccine, as measured through analysis of blood samples, were similar in the groups vaccinated using patches and those receiving intramuscular injection, and these immune responses were still present after six months. When asked after immunization, more than 70 percent of patch recipients reported they would prefer patch vaccination over injection or intranasal vaccination for future vaccinations.

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Unorthodox Treatment of Presumed Chronic Lyme Disease Can Be Deadly

MedicalResearch.com Interview with:

Dr. Christina Nelson, MD MPH Medical epidemiologist, Division of Vector-Borne Diseases CDC

Dr. Nelson

Dr. Christina Nelson, MD MPH
Medical epidemiologist, Division of Vector-Borne Diseases
CDC 

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

Response: Patients who are given a diagnosis of “chronic Lyme disease” have been offered a variety of treatments that have not been shown to be effective.  Many patients are treated with prolonged courses of antibiotics (for months or years), which have not been shown to provide substantial long-term benefit to patients.  Anecdotal reports about adverse outcomes associated with these treatments for chronic Lyme disease are common, but there have not been systematic efforts to collect data about the frequency of these events.

MedicalResearch.com: Why is the diagnosis of ‘Chronic Lyme Disease’ so common?

Response: The term “chronic Lyme disease” (CLD) has been used to describe people with different illnesses. While the term is sometimes used to describe illness in patients with Lyme disease, in many occasions it has been used to describe symptoms in people who have no evidence of a current or past infection with Lyme disease.  Because of the confusion in how the term CLD is employed, experts in this field do not support its use.

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FDA Approves BAXDELA™ (Delafloxacin) For Skin Infections

MedicalResearch.com Interview with:

Dr. Sue Cammarata, MD Chief Medical Officer Melinta Therapeutics

Dr. Cammarata

Dr. Sue Cammarata, MD
Chief Medical Officer
Melinta Therapeutics

MedicalResearch.com:   Would you explain what is meant by MRSA?

Response: MRSA is methicillin-resistant Staphylococcus aureus, a type of staph bacteria that is  resistant to many antibiotics. MRSA is noted by the CDC as one of the top 18 drug-resistant bacteria threats to the United States.  (from CDC https://www.cdc.gov/drugresistance/biggest_threats.html  ) 

MedicalResearch.com:   Why is infection with MRSA so serious?

Response:  MRSA can cause skin infections, lung infection and other issues.

If left untreated, MRSA infections can become severe and cause sepsis – a life-threatening reaction to severe infection in the body – and even death.  MRSA can also cause major issues, such as bloodstream infectionspneumonia and surgical site infections in a healthcare setting, such as a hospital or nursing home. “Resistance to first-line drugs to treat infections caused by Staphlylococcus aureus—a common cause of severe infections in health facilities and the community—is widespread. People with MRSA (methicillin-resistant Staphylococcus aureus) are estimated to be 64% more likely to die than people with a non-resistant form of the infection.”  (quote from WHO website http://www.who.int/mediacentre/factsheets/fs194/en/  )   Continue reading

Animal Visitation Programs Can Raise Infection Risks In Health Care Facilities

MedicalResearch.com Interview with:

Deborah Linder, DVM, MS, DACVN</strong> Research assistant professor Cummings School of Veterinary Medicine Tufts University and Associate director of the Tufts Institute for Human-Animal Interaction

Dr. Linder

Deborah Linder, DVM, MS, DACVN
Research assistant professor
Cummings School of Veterinary Medicine
Tufts University and
Associate director of the Tufts Institute for Human-Animal Interaction

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

Response: In our experience with our own therapy animal program, Tufts Paws for People, we have seen facilities and organizations put animals and people at risk by not following rigorous health and safety policies, and this certainly was confirmed by the results of our study. Lax health and safety policies typically aren’t intentional but occur as a result of enthusiasm for therapy animal programs without being aware of potential risks and what questions to ask. Also, it’s not just obvious problems that can occur, such as bites or allergies. It also can be an animal spreading infections due to diet or inadequate grooming, or unwanted stress on the animal.

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How Does HPV Virus Lead To Skin Cancer?

MedicalResearch.com Interview with:
Prof. Dr. med. Sigrun Smola
Institute of Virology, Saarland University
Homburg/Saar, Germany

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

Response: Non-melanoma skin cancer (NMSC), the most common cancer in humans, is caused by UV-irradiation. The potential co-factor role of cutaneous genus beta-human papillomaviruses (beta-HPV) in skin carcinogenesis, particularly in immunosuppressed patients, has become a major field of interest. However, the underlying mechanisms were unclear.

The skin has natural mechanisms providing protection against UV-induced damage. One important factor suppressing UV-induced skin carcinogenesis is the transcription factor C/EBPα belonging to the CCAAT/enhancer binding protein family. C/EBPα can induce cellular differentiation and is regarded as a tumor suppressor in various tissues. When C/EBPα expression is blocked in these tissues, tumorigenesis is enhanced.

Another important factor is the microRNA-203. It has been shown to control “stemness” in normal skin by suppressing a factor called p63. In many tumors miR-203 expression is shut off releasing this “brake”.

In our study we demonstrate that cutaneous beta-HPV interferes with both protective factors providing an explanation how cutaneous beta-HPV enhances the susceptibility to UV-induced carcinogenesis. Moreover, we provide evidence that these viruses regulate miR-203 via C/EBPα.

We have investigated this mechanism in Epidermodysplasia verruciformis (EV) patients that serve as a human model disease for studying the biology of genus beta-HPVs. They are highly susceptible to persistent genus beta-HPV infection, such as HPV8, and have an increased risk to develop non-melanoma skin cancer at sun-exposed sites.

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Efficacy of Recombinant Flu Vaccine in Adults 50 Years of Age or Older 

MedicalResearch.com Interview with:

Lisa M. Dunkle, M.D. Chief Medical Officer Protein Sciences Corporation 1000 Research Parkway Meriden, CT 

Dr. Dunkle

Lisa M. Dunkle, M.D.
Chief Medical Officer
Protein Sciences Corporation
1000 Research Parkway
Meriden, CT

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

Response: The first and only recombinant protein influenza vaccine (RIV, Flublok) was approved in 2013 as a trivalent formulation for use in adults 18 years of age and older. This approval was based on demonstration of clinical efficacy (full approval) in adults 18-49 years of age and accelerated approval was granted for adults 50 years of age and older. Two clinical trials were conducted in 2014-2015 with RIV4 (Flublok Quadrivalent), of which the trial reported in the current NEJM is one.

These studies supported full approval of Flublok in adults 50 years of age and older and approval of Flublok Quadrivalent in all adults 18 years of age and older. The second trial of immunogenicity of Flublok Quadrivalent in adults 18-49 years of age will be the subject of another publication in the near future.

The main findings of the current trial are well summarized in the Conclusion of the Abstract: “RIV4 provided better protection than standard-dose IIV4 against confirmed influenza-like illness in older adults.”

Additionally, the recombinant vaccine (RIV4, Flublok Quadrivalent) demonstrated significantly less injection site pain and tenderness following vaccination. Based on the characteristics of the study participants, one can conclude that RIV4 is safe and effective in most individuals with underlying chronic diseases

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The President’s Malaria Initiative Reduced All-Cause Childhood Mortality

MedicalResearch.com Interview with:

Alexsandra Jakubowski

Aleksandra Jakubowski MPH

Aleksandra Jakubowski, MPH PhD candidate
Department of Health Policy and Management
Gillings School of Global Public Health
University of North Carolina at Chapel Hill

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

Response: The US President’s Malaria Initiative (PMI) provides approximately $600 million annually to fund implementation of key evidence-based malaria prevention and treatment interventions, including insecticide treated nets (ITNs), artemisinin-based combination therapy (ACT), and indoor residual spraying (IRS) to populations in 19 recipient countries in sub-Saharan Africa (SSA). Despite this considerable investment, no study to date has evaluated the impact of PMI on population health outcomes. Previous evaluations have noted improved health outcomes in PMI countries, but comparison groups are needed to establish whether these changes were beyond the declining trends in mortality observed in the rest of the region. Our study sought to generate objective evidence for policy makers about the role this US-funded malaria aid program may have played in curbing child mortality in SSA.

We used a quasi-experimental design known as difference-in-differences to compare trends in health outcomes in PMI-recipient vs. PMI non-recipient countries. We analyzed publicly-available data from 32 countries in SSA spanning a period that included about ten years before and after the introduction of the program.

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Legionnaires’ Disease Is Widespread and Deadly in US Health Care Facilities

MedicalResearch.com Interview with:
Elizabeth A. Soda, MD
Epidemic Intelligence Service
Divison of Bacterial Diseases
National Center of Immunization and Respiratory Diseases
CDC

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

Response: Legionella is a waterborne bacterium responsible for Legionnaires’ disease, an often severe pneumonia. Legionnaires’ disease primarily affects certain groups of individuals such as those ≥50 year of age, current or former smokers, and those with chronic diseases or weakened immune systems. Health care facilities often have large and complex water systems and care for vulnerable populations that are susceptible to developing Legionnaires’ disease. Thus preventing hospitalized patients from developing Legionnaires’ disease is the ultimate goal. This analysis aimed to describe health care-associated Legionnaires’ disease in 2015 from the 21 U.S. jurisdictions that completely reported their health care-associated Legionnaires’ disease cases to the CDC’s Supplemental Legionnaires’ Disease Surveillance System (SLDSS).

Over 2,800 cases of Legionnaires’ disease cases were reported to SLDSS by the 21 jurisdictions, and 553 (20%) were considered health care associated. The analysis showed 16 of the 21 (76%) jurisdictions had at least one case of Legionnaires’ disease definitely related to a stay in a hospital or long-term care facility. In total there were 85 (3%) definite health care-associated Legionnaires’ disease cases (as defined by continuous exposure to a hospital or long-term facility for the entire 10 days before symptom onset) that resulted from 72 different health care facilities.

Additionally, 20 of 21 jurisdictions (95%) reported 468 (17%) possible health care-associated Legionnaires’ disease cases (as defined by any exposure to a health care facility for a portion of the 10 days before symptom onset) that resulted from approximately 415 different health care facilities.

While approximately 9% of Legionnaires’ disease cases overall are fatal, this report showed a case fatality of 25% for definite health care-associated cases.

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Outcomes of Hospital-Onset Multidrug Resistant Pseudomonas aeruginosa

MedicalResearch.com Interview with:

Sanjay Merchant, PhD Executive Director Center for Observational and Real-world Evidence (CORE) Merck

Dr. Merchant

Sanjay Merchant, PhD
Executive Director
Center for Observational and Real-world Evidence (CORE)
Merck

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

Response: In February, the World Health Organization (WHO) published its first ever list of antibiotic-resistant “priority pathogens” that pose the greatest threat to human health. The list highlights in particular the threat of gram-negative bacteria that are resistant to multiple antibiotics, referred to as multidrug-resistant (MDR) bacteria, which have built-in abilities to find new ways to resist treatment. MDR Pseudomonas aeruginosa (MDR PsA) is listed as one of the pathogens in the Critical category in terms of need for new therapies. It poses an urgent threat.

We set out to better understand the clinical and economic burden associated with hospital-onset MDR PsA so that appropriate treatment strategies can be employed to mitigate resistance. Our findings were presented at ASM Microbe 2017.

Mortality rates for hospital-onset MDR PsA patients (20.1%) were almost twice as high compared to patients who did not have MDR PsA (11.5%). The MDR PsA patient group had a significantly higher odds ratio for mortality even after controlling for various factors that may impact mortality.

Hospital-onset MDR PsA patients spent six additional days in the hospital when compared to patients who did not have MDR PsA infectionsThese findings highlight the public health threat of MDR PsA among hospitalized patients and the need for timely and effective therapy.

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