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Communicable Diseases clinical trials

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NCT ID: NCT03241355 Completed - Diet Modification Clinical Trials

Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

Start date: September 16, 2013
Phase: N/A
Study type: Interventional

The study aims to explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children during a winter period.

NCT ID: NCT03239899 Completed - HIV Infections Clinical Trials

PD-1 Inhibition to Determine CNS Reservoir of HIV-Infection

Start date: April 9, 2018
Phase: Phase 1
Study type: Interventional

Background: HIV affects millions of people. The disease may "hide" in the brain, even in people with well-controlled HIV without cancer. Then it may "wake up" and continue. The drug pembrolizumab uses the body's immune system to fight cells like cancer cells. It is approved to treat some cancers but not HIV. Researchers want to see if it is safe for HIV-positive people without cancer. This study is not for HIV treatment; only one dose of the drug will be used. Objective: To learn if the drug pembrolizumab, used to treat certain cancers, is safe for HIV-positive people. Eligibility: Adults ages 18 and older with HIV who are in another NIH protocol Design: Participants will be screened with: - Medical history - Physical and neurological exams - Blood tests - Lumbar puncture. The lower back will be numbed. A needle will remove fluid from between back bones. - FDG-PET/CT. A radioactive sugar will be injected in a thin plastic tube (catheter) inserted in an arm vein. Participants will rest for an hour, urinate, then lie in the scanner. A mask will hold the head still. - Leukapheresis. An optional procedure at baseline. White blood cells are removed from you using a serum cell separator machine Women who can become pregnant cannot take pembrolizumab. Men who take it must use 2 kinds of contraception. Participants will have up to 7 more visits, which repeat some screening tests. At 1 visit, participants will get one dose of pembrolizumab by catheter for 30 minutes. They will get allergy and pain medicines. At 2 visits, participants will have a brain MRI. They will get a contrast agent by catheter. They will lie in a metal cylinder that takes pictures for 1-2 hours. They will get earplugs for loud sounds.

NCT ID: NCT03239665 Completed - Influenza Clinical Trials

Vaccination Education Through Pharmacists and Senior Centers (VEPSC)

VEPSC
Start date: October 10, 2017
Phase: N/A
Study type: Interventional

The study consists of two arms (PHARM and PEER) designed to educate participants about three vaccine-preventable diseases (zoster, pneumonia, and influenza) and vaccination. PHARM will consist of a 60-minute presentation about the three vaccine-preventable diseases and their vaccinations delivered by a pharmacist, featuring a didactic lecture and discussion supplemented by video clips of community members discussing their experiences around vaccination, as well as physicians underscoring the importance of vaccination. PEER will consist of a 60-minute small-group session led by a peer educator which includes scripted roleplaying exercises designed to reinforce learnings pertaining to these three vaccine-preventable diseases and their vaccinations. The components of these interventions will be designed to address specific barriers to vaccination identified by literature search and our prior work in the area of community-based vaccine education. Both arms will focus primarily on pneumococcal disease and zoster but will include limited content on influenza because participants are likely to have questions about how the flu and its vaccination differ from pneumococcal diseases and zoster. The study will be implemented in an older, predominantly African-American (AA) population, consistent with our prior work in this area.

NCT ID: NCT03235947 Completed - Clinical trials for Urinary Tract Infection

Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients

PERIFOS
Start date: September 7, 2016
Phase: Phase 4
Study type: Interventional

A clinical controlled, randomized and double blind trial that included adult patients (≥18 years) receiving kidney transplantation (KT) at the INCMNSZ. The intervention group will receive disodium fosfomycin 4 g intravenously in three moments: preoperative of transplant surgery, prior to removal of the urinary catheter and finally prior to removal of ureteral catheter. The control group will receive placebo in the same moments. Both groups will receive prophylaxis standard for urinary tract infection (UTI), with trimethoprim/sulfamethoxazole 160/800 mg per day. This prophylaxis will be administered once the estimated glomerular filtration rate is greater than 30 mL/min/1.73m2. The primary objective is to compare the average number of episodes of UTI´s and asymptomatic bacteriuria in both groups after 7 weeks of follow-up. The secondary objectives are to know the incidence of asymptomatic bacteriuria, the incidence of hospitalizations for IVU, the days of hospital stay, the pattern of bacterial resistance, the safety of disodium fosfomycin, and assessment of the function of the graft and rejection rate.

NCT ID: NCT03234036 Completed - HIV Infections Clinical Trials

A Two-part Study to Compare a Tablet and Capsule Formulation of GSK2838232 With and Without Food, and to Assess the Safety and Drug Levels of Repeated Once-daily Doses of GSK2838232 Without Ritonavir

Start date: August 2, 2017
Phase: Phase 1
Study type: Interventional

This study will be conducted in two Parts to confirm the acceptability/selection of a tablet formulation for future clinical development of GSK2838232. Part 1 of the study will assess single ritonavir (RTV)-boosted doses of a new tablet formulation given with food (containing approximately 30% fat) against the reference capsule formulation also given with food and then will assess the impact of fasted conditions on the tablet performance. In Part 2, non-boosted GSK2838232 will be given as once-daily tablet doses for 11 days in a separate group of subjects, assuming the tablet performance is considered acceptable from Part 1. Approximately 16 healthy subjects will be enrolled to provide at least 12 evaluable subjects through the three study periods in Part 1. 10 healthy subjects will be enrolled to provide at least 8 evaluable subjects through the single study period in Part 2. The maximum duration of study participation will be approximately 9 to 10 weeks for Part 1; and 8 to 9 weeks for Part 2.

NCT ID: NCT03233438 Completed - Clinical trials for Bacterial Infections

Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Start date: July 24, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the effect of a new critical pathway (use of guideline-based patient identification criteria and for those who meet these criteria, use of dalbavancin) compared to usual care for the treatment of ABSSI (Acute Bacterial Skin and Skin Structure Infections)

NCT ID: NCT03231943 Completed - HIV Infections Clinical Trials

GSK3640254 First Time in Human (FTIH) Study in Healthy Volunteers

Start date: September 19, 2017
Phase: Phase 1
Study type: Interventional

Human immuno deficiency virus 1 (HIV-1) infections continues to be a serious health threat throughout the world and development of medicines with new mechanism of action have an important role to play. GSK3640254 is a maturation inhibitor (MI) and can be effective in HIV-1 treatment. This randomized, 2-part, single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of in healthy subjects for GSK3640254. The information collected in this study will help in further clinical development of GSK3640254, including a Phase IIA Proof of Concept (PoC) study in HIV-infected subjects. Approximately 16 healthy subjects will be randomized to receive single oral dose of GSK3640254 and placebo in Part 1 and approximately 56 healthy subjects will be randomized to receive repeat oral dose of GSK3640254 or placebo in Part 2. All doses will be given immediately after a moderate fat meal. Maximum duration of study participation will be approximately 12 weeks.

NCT ID: NCT03230916 Completed - Clinical trials for Suspected or Documented Gram-negative Bacterial Infection

A Pharmacokinetics Study of MK-7655A in Pediatric Participants With Gram-negative Infections (MK-7655A-020)

Start date: November 6, 2017
Phase: Phase 1
Study type: Interventional

This study aims to obtain plasma pharmacokinetic (PK) data and characterize the PK profile of imipenem (IMI), cilastatin (CIL), and relebactam (REL) following administration of a single intravenous (IV) dose of MK-7655A (a fixed ratio combination of imipenem/cilastatin/relebactam), hereafter referred to as IMI/REL.

NCT ID: NCT03230838 Completed - Pyelonephritis Clinical Trials

MK-7625A Versus Meropenem in Pediatric Participants With Complicated Urinary Tract Infection (cUTI) (MK-7625A-034)

Start date: April 26, 2018
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the safety and tolerability of MK-7625A (ceftolozane/tazobactam) compared with that of meropenem in pediatric participants with cUTI, including pyelonephritis.

NCT ID: NCT03226119 Completed - HTLV-I Infections Clinical Trials

MP Diagnostics HTLV Blot 2.4 Post-Market Clinical Study

Start date: January 15, 2018
Phase: Phase 4
Study type: Interventional

This post-market study is intended to assess the performance of the HTLV Blot 2.4 in repository serum/plasma specimens with neurological disorders (n=100) or an HTLV known positive infection (n=50).