A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 For Prevention of Recurrent Clostridioides Difficile Infection

Date Added
September 12th, 2024
PRO Number
Pro00135241
Researcher
Scott Curry

List of Studies


Keywords
Infectious Diseases
Summary

The primary objective of this study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate in participants who receive a 14-day course of VE303 or matching placebo.
Other objective is to measure health-related quality of life and daily CDI symptoms in participants treated with VE303 versus placebo.

Institution
MUSC
Recruitment Contact
Alicia Hartley
843-792-4100
hartleal@musc.edu

Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections In Pediatric Transplant Recipients.

Date Added
March 21st, 2024
PRO Number
Pro00134622
Researcher
Lauren Powell

List of Studies

Keywords
Infectious Diseases, Pediatrics, Transplant
Summary

Hematopoietic cell transplantation (HCT) and solid organ transplantation (SOT) recipients are at high risk for respiratory viral infection (RVI). This study aims to establish a comprehensive RVI diagnostic and disease progression predictive model in children undergoing HCT and SOT. Findings will result in the first ever evidence-based pediatric guidelines.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-901-4153
alsarral@musc.edu

REBYOTA™ for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study

Date Added
August 8th, 2023
PRO Number
Pro00130739
Researcher
Scott Curry

List of Studies


Keywords
Bowel, Infectious Diseases
Summary

This is a prospective observational cohort study that will create a patient registry by collecting data on patients who receive REBYOTA to prevent recurrence of Clostridioides difficile infection (CDI). The registry will include data about CDI episodes, CDI related symptoms, healthcare resource utilization (i.e., hospitalizations and re-admissions) and this data will be collected up to 6-months after receiving REBYOTA™.

Institution
MUSC
Recruitment Contact
Alicia Hartley
843-792-4100
hartleal@musc.edu

A Prospective, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of PMX Cartridge in Addition to Standard Medical Care for Patients with Endotoxemic Septic Shock

Date Added
December 7th, 2022
PRO Number
Pro00122530
Researcher
Blaithin McMahon

List of Studies


Keywords
Blood Disorders, Hypertension/ High Blood Pressure, Infectious Diseases, Kidney
Summary

The purpose of this study is to compare the safety and efficacy of the PMX cartridge ( Toramyxin) (in Addition to Standard Medical Care for Patients with Endotoxemic Septic Shock:
Eligible and consented subjects will be randomized to receive either the PMX cartridge (administered twice for 1½ to 2 hours per treatment session approximately 24 hours apart) plus standard medical care or standard medical care alone. For all subjects in whom treatment has been initiated, a follow-up visit (if they are still in the hospital) or a telephone call will be completed at Day 28 (or later) to determine their mortality status. In surviving subjects, a follow-up visit or telephone call to determine their mortality status will also take place at approximately three months (i.e. Day 90) and 12 months after the subject was randomized.

Institution
MUSC
Recruitment Contact
Marcie Pregulman
843-792-8166
pregulma@musc.edu

Immunobiology of Influenza Critical Illness in Young People (PICFLU2)

Date Added
November 24th, 2021
PRO Number
Pro00112536
Researcher
Sara Rhodes Proctor Short

List of Studies

Keywords
Infectious Diseases, Pediatrics
Summary

The Pediatric Intensive Care Influenza Study #2 (PICFLU2) is a multiyear, multicenter prospective observational study in patients aged ≤ 21 years hospitalized in pediatric Intensive Care Units (PICUs) and Stepdown (or intermediate) Care Units (SDUs) in the US designed to evaluate of the immunobiology of influenza virus-related critical illness in young hosts.

Institution
MUSC
Recruitment Contact
Lauren Wakefield
843-792-0603
wakefila@musc.edu



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