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NCT ID: NCT03940586 Completed - Clinical trials for Cytomegalovirus (CMV) Infection

Letermovir Treatment in Pediatric Participants Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT) (MK-8228-030)

Start date: August 8, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the pharmacokinetics (PK) of letermovir (LET) in pediatric participants. Participants will be enrolled in the following 3 age groups: Age Group 1: From 12 to <18 years of age (adolescents); Age Group 2: From 2 to <12 years of age (children); and Age Group 3: From birth to <2 years of age (neonates, infants and toddlers). All participants will receive open label LET for 14 weeks (~100 days) post-transplant, with doses based on body weight and age.

NCT ID: NCT03931941 Completed - Infection Clinical Trials

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)

CD3-OLS
Start date: July 30, 2019
Phase: Phase 3
Study type: Interventional

This is a prospective, multicenter, open-label Phase 3 study of a microbiota suspension of intestinal microbes. Patients who have had at least one recurrence of CDI after a primary episode and have completed at least one round of standard-of-care oral antibiotic therapy or have had at least two episodes of severe CDI resulting in hospitalization may be eligible for the study. Subjects may receive a second RBX2660 enema if they are deemed treatment failures following the initial enema per the protocol-specified treatment failure definition.

NCT ID: NCT03931538 Completed - Clinical trials for Urinary Tract Infections

Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study

RapIDMixAR
Start date: July 17, 2018
Phase: N/A
Study type: Interventional

In this protocol, investigators are examining the ability for a novel multiplex PCR assay with mixed floral antibiotic resistance profiling is safe and increases effective treatment for urinary tract infections in a urology clinic over traditional culture methods alone and decreases retreatment rates in this population.

NCT ID: NCT03931408 Active, not recruiting - Clinical trials for Spinal Cord Injuries

Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections

Start date: February 19, 2019
Phase: Phase 2
Study type: Interventional

Participants will undergo daily gentamicin bladder instillations to determine if its use will reduce the rate of symptomatic urinary tract infections (UTIs) as well as the use of oral and intravenous antibiotics in adults with chronic spinal cord injury (SCI) who have recurrent UTIs. Participants are randomized into one of three groups: 1) Gentamicin and saline instillation 2) Saline only instillation 3) Standard of care, no instillation.

NCT ID: NCT03930615 Completed - Clinical trials for Cytomegalovirus Infection

Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040)

Start date: June 21, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the safety and efficacy of letermovir (LET) versus placebo when cytomegalovirus (CMV) prophylaxis was extended from 100 days to 200 days post-transplant in CMV seropositive participants who received an allogenic hematopoietic stem cell transplant (HSCT). It was hypothesized that LET is superior to placebo in the prevention of clinically-significant CMV infection when LET prophylaxis is extended from 100 to 200 days.

NCT ID: NCT03925480 Completed - Clinical trials for Bacterial Infections

Preventing Young Infant Infections Using Azithromycin in Labour (PreYIAL) Trial

PreYIAL
Start date: July 1, 2019
Phase: Phase 3
Study type: Interventional

A trial to assess cumulative incidence of skin and soft tissue infections (SSTI) in infants (by three months of age) born to mothers receiving a single-dose of 2 grams of oral azithromycin during labour (or immediately prior to delivery in the case of caesarean section), compared to infants whose mothers received placebo.

NCT ID: NCT03924934 Enrolling by invitation - Clinical trials for Enterobacteriaceae Infections

Community-associated Highly-Resistant Enterobacterales

COCARE
Start date: May 1, 2019
Phase:
Study type: Observational

This is a prospective multi-center study. Bacterial isolates from hospitalized patients with CA-HRE will be compared to those from hospitalized patients with healthcare-associated HRE (HA-HRE). In addition, community spread of CRE will be determined.

NCT ID: NCT03924219 Active, not recruiting - Clinical trials for Kidney Transplant Infection

CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients

Start date: June 3, 2019
Phase:
Study type: Observational

CMV infection and disease remain a significant clinical challenge for pediatric solid organ transplant (SOT) recipients. Current prevention strategies are limited to prophylaxis in which antiviral medication is administered for a period of several months or preemption in which close monitoring of CMV viral load from the peripheral blood is performed and treatment is initiated when CMV is detected. Each of these strategies has risks, costs, and limitations associated with it. Recently, assays for measurement of an individual patient's CMV immunity have been developed and are clinically available. One of these is the Viracor CMV T cell Immunity Panel. This flow cytometry based assay is performed on peripheral blood and measures cytokine release in response to CMV antigen stimulation by flow cytometry. The thresholds for this assay that confer protection against CMV infection in pediatric SOT recipients are not known. Defining CMV-specific cell mediated immune response thresholds that confer protection against CMV reactivation could inform patient specific durations of antiviral prophylaxis or pre-emptive surveillance testing. Therefore, the objective of this study is to quantify CMVresponsive T lymphocyte populations by flow cytometry (Viracor CMV T cell Immunity Panel) in pediatric heart, kidney, and liver transplant recipients within the first year of transplantation and to investigate potential threshold values that correlate with protection against CMV infection (DNAemia).

NCT ID: NCT03922971 Completed - Infection Clinical Trials

Post-Endoscopic Infection Rate Notifications to Improve the Delivery of Care

Start date: August 7, 2019
Phase: N/A
Study type: Interventional

This project will notify centers of center's post-endoscopic infection rates and evaluate the effectiveness of this notification system to decrease infection rates. The investigators aim to notify centers of the number of patients and center's risk-adjusted rates of hospitalizations for infections after colonoscopy and esophagogastroduodenoscopy (EGD) procedures performed between January 2015 and September 2018. The investigators will randomize centers to two notification groups: (1) Ability to view center's rate compared with all other centers (ASCs and outpatient centers notified and compared separately) or (2) Ability to view center's rate compared with the other centers with a similar patient comorbidity profile and in addition to viewing option 1. Facilities will answer questions about center's infection control practices. The investigators hypothesize that centers with high rates of post-procedural infections will (1) be more likely to report that the center took action to investigate the center's infection control practices after the first notification and (2) observe a decrease in infections after the notification. The investigators anticipate that centers with high rates of post-procedural infections that are randomized to group 2 will have greater change. The investigators anticipate no change in rates of infection in the facilities that had zero or very low (n=1) event rates.

NCT ID: NCT03920709 Recruiting - HIV Infections Clinical Trials

Analysis of the Nasal Mucosal Immune Response in HIV Infection

HYSOPE
Start date: June 2, 2021
Phase:
Study type: Observational

The principal objective is to define and compare the viral reservoir, mucosal immune responses and the microbiota of different HIV infection stages; viremic, aviremic (under treatment), natural elite controllers; The secondary objective is to compare the mucosal immune response and microbiota of HIV patients with the healthy control population of Milieu Interieur;