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Communicable Diseases clinical trials

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NCT ID: NCT02826018 Terminated - Hepatitis B Clinical Trials

A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection

Start date: June 24, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALN-HBV in healthy adult volunteers and patients with chronic hepatitis B virus (HBV) infection. In addition, the study will assess antiviral efficacy of ALN-HBV in patients with HBV.

NCT ID: NCT02806141 Terminated - Clinical trials for Pneumonia, Ventilator-Associated

Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates

Start date: September 2016
Phase: Phase 3
Study type: Interventional

This study is planned to compare the clinical efficacy and safety of aerosolized plus intravenous colistin vs. intravenous colistin as adjunctive therapy for the treatment of ventilator-associated pneumonia (VAP) due to pandrugs-resistant (PDR) Acinetobacter baumannii in the neonates.

NCT ID: NCT02707900 Terminated - HIV-1 Infection Clinical Trials

Pilot Trial of the Effect of Vorinostat and AGS-004 on Persistent HIV-1 Infection

VORVAX
Start date: March 2016
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to 1) evaluate the safety of a series of injections with the AGS-004 product in combination with a series of Vorinostat doses and 2) to help scientists evaluate ways of reactivating latent (non-acting) HIV virus and determine if the immune system can be made stronger to eliminate the activated HIV virus.

NCT ID: NCT02688790 Terminated - Clinical trials for Bacterial Infections

Study Evaluate the PK Profile of Dalbavancin in Infants and Neonates Patients With Known or Suspected Bacterial Infection

Start date: April 1, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the Pharmacokinetic (PK) profile of a single intravenous (IV) infusion dose of dalbavancin, and to evaluate the safety and tolerability of a single dalbavancin IV infusion.

NCT ID: NCT02613403 Terminated - Hepatitis C Clinical Trials

Efficacy and Safety of Grazoprevir (+) Uprifosbuvir (+) Ruzasvir (MK-3682B) (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)

Start date: December 10, 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, multicenter, 2-part, open-label trial of the combination regimen of grazoprevir (GZR [MK-5172]; 100mg), uprifosbuvir (UPR [MK-3682]; 450 mg) and ruzasvir (RZR [MK-8408]; 60 mg) with and without Ribavirin (RBV) in cirrhotic (C) or non-cirrhotic (NC) participants infected with hepatitis C virus (HCV) previously failing a direct-acting antiviral regimen (DAA). The combination regimen, referred to as MK-3682B, will be administered as two fixed-dose combination (FDC) tablets, given once-daily. The study will evaluate the efficacy of MK-3682B with or without RBV as assessed by the proportion of participants achieving Sustained Virologic Response 12 weeks (SVR12) after the end of all study therapy.

NCT ID: NCT02593851 Terminated - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

Start date: December 4, 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate pharmacokinetics, safety, tolerability, antiviral activity, and impact on the clinical course of Respiratory Syncytial Virus (RSV) infection after multiple oral doses of JNJ-53718678 at different doses and/or dosing regimens in infants (greater than [>] 1 month to less than or equal to [<=] 24 months of age) who are hospitalized with RSV infection.

NCT ID: NCT02547129 Terminated - Clinical trials for Prosthetic Joint Infection of the Knee

Static vs. Articulating Antibiotic Spacer for Periprosthetic Joint Infection in Total Knee Arthroplasty

Start date: September 2015
Phase: N/A
Study type: Interventional

The primary aim of the study is to compare two techniques for treatment of total knee infection: resection total knee arthroplasty with an articulating (motion in the joint) spacer and resection total knee arthroplasty with a static (no motion in the joint) spacer.

NCT ID: NCT02537964 Terminated - Clinical trials for Infectious Disease Transmission

Effectiveness of Chlorhexidine Bathing in the Neonatal Intensive Care Unit

Start date: September 2016
Phase: N/A
Study type: Interventional

This is a prospective, controlled; crossover study of daily bathing with no-rinse, 2% chlorhexidine gluconate (CHG) impregnated washcloths versus bathing with water/soap or water according to gestational age and weight (e.g. standard bathing). The trial will take place in the Neonatal intensive care unit (NICU). Baseline data ragarding bloodstream infections (BSI) and colonization with multidrug resistant orgnisms (MDRO) will be collected for 3-6 months prior to patient enrollment. In the preliminary phase of the study we will establish the safety of chlorhexidine bathing using Clinell ® Chlorhexidine wash cloths on three groups of patients: term infants admitted to the NICU; late preterm infants (34-37 weeks); preterm infants 30-34 weeks of gestation. Interim analysis for adverse events will be performed after each group of patients. In the subsequent phases of the study, all infants admitted to the NICU and enrolled in the study will be bathed three times a week with Chlorhexidine wash cloths during the initial 6-months study period (intervention), followed by standard bathing during the second 6-months period, then again intervention period for 6 months and standard bathing for 6-months. Total study period- 3 years. Data collection will include all bloodstream infections as well as surveillance cultures

NCT ID: NCT02527460 Terminated - HIV Infections Clinical Trials

Anakinra, A Recombinant Human IL-1 Receptor Antagonist for Neuroinflammation in HIV-1 Infection

Start date: August 17, 2015
Phase: Phase 1
Study type: Interventional

Background: HIV can sometimes cause HIV-associated neurocognitive disorder, or HAND. HAND is HIV-associated neurocognitive disorder. It can affect memory, thinking, or concentration. It can cause mood changes. HAND may be caused by HIV hiding in the central nervous system then causing inflammation. Researchers want to see if a drug for inflammation (Anakinra) can help people with HIV. Objective: To see if a drug for inflammatory diseases is safe for people with HIV-infection on antiretroviral therapy. Eligibility: Adults 18-61 years old with HIV who are enrolled in another study. Design: Participants will be screened with medical history, physical exam, and blood and urine tests. Participants will have up to 15 study visits over 16 weeks. At study visit 1, participants will have: - Screening tests repeated. - Brain magnetic resonance imaging (MRI) scans. They will lie on a table that slides into a metal cylinder in a strong magnetic field. They will get a dye inserted by a thin plastic tube in a vein. - Lumbar puncture. The lower back will be numbed. A needle will collect fluid from between bones in the back. - Tests of memory, thinking, and attention. Participants may also fill out forms and do tasks. Participants will learn how to inject the study drug. Over 8 weeks, they will give themselves the study drug at home every day. They will do up to 3 injections at once. They will write down their injections and any side effects. Participants will have 5 weekly visits while taking the study drug. They will answer questions and have blood drawn. At weeks 8 and 16, they will have a visit that repeats visit 1.

NCT ID: NCT02510300 Terminated - Clinical trials for Hepatitis C Virus Infection

A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials

Start date: October 21, 2015
Phase:
Study type: Observational [Patient Registry]

This Registry will enroll adolescent and pediatric participants who received at least one Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a Gilead-sponsored chronic hepatitis C clinical trial. The primary objective of this Registry is to determine the long-term safety of anti-HCV regimens in the pediatric population. Secondary objectives of this Registry are to determine whether subsequent detection of HCV RNA in participants who relapse following sustained virologic response (SVR) represents the re-emergence of pre-existing virus, the development of resistance mutations, or whether it is due to re-infection, and to characterize resistance mutations and the persistence of resistance mutations in pediatric participants who did not achieve SVR. Once enrolled, participants will be followed for up to 5 years.