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

A trial of transplanting Hepatitis C-viremic kidneys into Hepatitis C-Negative kidney recipients (THINKER-NEXT)

Date Added
July 3rd, 2022
PRO Number
Pro00119881
Researcher
John McGillicuddy

List of Studies

Keywords
Infectious Diseases, Kidney, Transplant
Summary

This research study is being done to determine whether it is safe to give a kidney transplant from a donor with hepatitis C to a patient without hepatitis C. This study is looking for participants in need of a kidney transplant who are willing to accept a kidney from a patient with hepatitis C.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

CONNECTS Master for Clinical Trials targeting macro-, micro-immunothombosis, vascular hyperinflammation, and hypercoagulability and rein-angiotensin-aldosterone system (RAAS) in hospitalized patients with COVID-19 (ACTIV-4 Host Tissue)

Date Added
March 24th, 2022
PRO Number
Pro00114224
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary
Summary

The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response with agents targeting the RAAS improves clinical outcomes among patients with COVID-19.
Potential agents to investigate on this platform include TXA127 and TRV027. Both have potential beneficial effects on the RAAS system in COVID-19. We postulate that SARS-CoV-2 spike protein interaction with the ACE2 receptor leads to unchecked activity of AngII, and RAAS-targeting therapies will counterbalance pathologic RAAS effects. We will evaluate the efficacy of TXA127 and TRV027 in restoring RAAS balance.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 24 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)

Date Added
January 4th, 2022
PRO Number
Pro00113213
Researcher
Ronald Teufel

List of Studies


Keywords
Infant, Infectious Diseases
Summary

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract. infection (LRTI) among infants and young children, resulting in annual epidemics worldwide. Despite more than 50 years of attempted vaccine development, there are no licensed vaccines. While RSV prevention exists in the form of a specific RSV IgG (palivizumab) requiring 5 once monthly injections, it is licensed only for infants who experience the greatest morbidity and mortality from RSV: preterm infants born ≤ 35 weeks GA, children with chronic lung disease of prematurity, children with hemodynamically significant congenital heart disease. EDP-938 is a novel, orally administered, non-fusion replication inhibitor of respiratory syncytial virus (RSV) that is being developed as a potential treatment for RSV infection.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-3394
bickfome@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

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 180-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 180-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Chester Medical Center
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 180-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


Keywords
COVID-19, Coronavirus, Drug Studies, Infectious Diseases, SARS-CoV-2
Summary

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 180-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu



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