CARDIOVASCULAR INFECTION DIAGNOSIS USING METAGENOMICS AND PREDICTING APPROACH TO APPROPRIATE CLINICAL TESTING: THE IMPACT STUDY

Date Added
August 13th, 2025
PRO Number
Pro00144819
Researcher
Courtney Harris

List of Studies

Keywords
Cardiovascular, Infectious Diseases
Summary

To describe current real-world utilization of mcfDNA testing for CV infections using a multi-center retrospective registry. We will develop multi-center REDCap database of mcfDNA use in valvular IE and/or CIED lead infections and summarize patient demographics and clinical characteristics of IE and CIED lead infection cases. We will assess common scenarios/indications for which mcfDNA is sent and timing of the test. Clinically relevant microbiological yield of mcfDNA in IE and/or CIED lead infections will be described.

To identify clinical predictors where mcfDNA outperforms CMT. We will assess clinical characteristics of patients with IE and CIED lead infection in whom mcfDNA has higher microbiologic yield compared to CMT. We will develop a prediction model/scoring system to identify subgroup of patients in whom mcfDNA should be sent early (after 48 hours of negative CMT).

To analyze clinical impact of mcfDNA testing in patients with valvular IE and/or CIED lead infections. We will classify cases as having Positive vs. Negative vs. Neutral impact using pre-specified definitions and assess predictor of positive clinical impact.

Institution
MUSC
Recruitment Contact
Courtney Harris
8437924549
harricou@musc.edu

Phase 3, Randomized, Controlled, Open-label Study to Compare the Efficacy and Safety of Bemnifosbuvir-Ruzasvir Fixed-dose Combination (BEM/RZR FDC) Versus Sofosbuvir-Velpatasvir Fixed-dose Combination (SOF/VEL FDC) in Subjects with Chronic Hepatitis C Virus (HCV) Infection

Date Added
August 1st, 2025
PRO Number
Pro00143821
Researcher
Eric Meissner

List of Studies


Keywords
Infectious Diseases
Summary

The purpose of this clinical research study is to evaluate the safety and effectiveness of the investigational drug called bemnifosbuvir-ruzasvir (BEM/RZR) in comparison to the FDA approved comparator drug in treating chronic Hepatitis C Virus (HCV) infection.

Institution
MUSC
Recruitment Contact
Jamila Williams
(843) 792-1088
keithja@musc.edu

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



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