A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY) Save

Date Added
September 24th, 2019
PRO Number
Pro00090069
Researcher
Andrew Atz

List of Studies


Profiles_link
Keywords
Infant, Infectious Diseases, Pediatrics
Summary

The purpose of this study is to evaluate how effective MEDI8897 is at preventing lung disease caused by Respiratory Syncytial Virus (RSV) and to evaluate the safety and tolerability of MEDI8897 in healthy infants compared with placebo. A placebo is a saline solution that looks like the study drug but it does not contain the active ingredient.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
2-1213
choudhar@musc.edu

A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY) Save

Date Added
August 27th, 2019
PRO Number
Pro00090138
Researcher
Andrew Atz

List of Studies


Profiles_link
Keywords
Infant, Infectious Diseases, Pediatrics
Summary

MEDLEY is a clinical study researching an investigational medication called MEDI8897, for babies at high risk for respiratory syncytial virus (RSV) disease. The study is looking to see how safe MEDI8897 is, and if it works as well as a medication, Synagis, already approved to protect against RSV.
Babies may be eligible for the study if they are in their first year of life and:
? were born prematurely (at 35 weeks or earlier) or have a heart or lung condition
? have not received any RSV preventive medication. Subjects will receive 5 monthly intramuscular injections throughout RSV season (October to March)

Institution
MUSC
Recruitment Contact
Kalyan Chundru
2-1213
choudhar@musc.edu

Effects of GLP-l Receptor Agonists on Cardiometabolic Alterations in HIV-associated Lipohypertrophy Save

Date Added
July 17th, 2019
PRO Number
Pro00088171
Researcher
Allison Eckard

List of Studies

Silhouette
Keywords
Body Composition, Cardiovascular, Drug Studies, Healthy Volunteer Studies, HIV / AIDS, Immune System, Infectious Diseases, Inflammation, Insulin, Liver, Metabolism, Minorities, Obesity, Weight Control
Summary

This is a randomized, double-blinded, placebo-controlled phase 2b clinical trial to characterize, examine and compare the effects of GLP-1 receptor agonist (semaglutide) in HIV-infected adult individuals with lipohypertrophy versus healthy controls with obesity but without HIV.

The two populations will be studied in separate but similarly-designed studies running in parallel.

Subjects in both populations will be assigned by chance (1:1) to semaglutide or placebo.

Institution
MUSC
Recruitment Contact
Lisa Martin
(843) 876-5699
martinl@musc.edu

Multicenter Randomized Pragmatic Clinical Trial Comparing Two-versus-Three Antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease Save

Date Added
July 16th, 2019
PRO Number
Pro00089685
Researcher
Patrick Flume

List of Studies


Profiles_link
Keywords
Infectious Diseases, Lung, Pulmonary
Summary

The purpose of this study is to better understand treatment practices for Mycobacterium avium complex (MAC) disease. This study is comparing the effectiveness and tolerability of taking 2 drugs compared to 3 drugs in people with MAC disease.

Institution
MUSC
Recruitment Contact
Abigail Grady
843-792-2072
gradyabi@musc.edu

Study to Understand Disease Course Inflammation and Endotype of South Carolinians with Nontuberculous Mycobacteria Save

Date Added
June 18th, 2019
PRO Number
Pro00089284
Researcher
Bryan Garcia

List of Studies

Silhouette
Keywords
Healthy Volunteer Studies, Infectious Diseases, Lung, Non-interventional, Pulmonary
Summary

The goal of this cohort and biorepository is to collect data and blood specimens on individuals with Nontuberculous Mycobacteria (NTM), pulmonary disease, and healthy adults to better understand the illness and ultimately improve the care and survival of those with these conditions.

Institution
MUSC
Recruitment Contact
Abigail Grady
843-792-2072
gradyabi@musc.edu

PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RELTECIMOD AS COMPARED TO PLACEBO IN ADDITION TO STANDARD OF CARE IN PATIENTS WITH SEPSIS-ASSOCIATED ACUTE KIDNEY INJURY (SA-AKI) Save

Date Added
April 9th, 2019
PRO Number
Pro00086843
Researcher
Heather Evans

List of Studies

Silhouette
Keywords
Infectious Diseases, Kidney
Summary

The purpose of the study is to test the effectiveness and safety of Reltecimod, an investigational drug, on patients with acute kidney injury associated with serious infections. The drug will be administered at a dose of 0.5 mg/kg as an intravenous infusion given over 10 minutes. There are a total of 11 study visits- only one of which involves IMP administration. The other nine visits are for follow-up of the participant's condition over a three month period. The majority of these visit will be completed by the end of the fist 30 days of the participants' trial timeline.

Institution
MUSC
Recruitment Contact
Jason Hirsch
843-792-8824
hirschj@musc.edu

SHARPS Antibiotic Resistance, Prescribing, and Efficacy among Children Save

Date Added
October 16th, 2018
PRO Number
Pro00082617
Researcher
Robert Daniels

List of Studies

Keywords
Infectious Diseases, Pediatrics
Summary

This survey aims to monitor rates and practices of antibiotic prescribing in children around the world in order to identify trends and areas for improvement in the prudent use of antibiotics. Comparisons of this scale involving data collected in a standardized format have never been performed before. The primary aim of this study is to collect data on antimicrobials prescribed to all hospitalized patients at participating centers over a 24 hour period.

Institution
Palmetto
Recruitment Contact
Robert Daniels
8034343797
robert.daniels@palmettohealth.org

Impact of an Emergency Room Urinary Tract Antimicrobial Stewardship Intervention Save

Date Added
May 23rd, 2018
PRO Number
Pro00074146
Researcher
Hana Winders

List of Studies

Keywords
Infectious Diseases, Urinary
Summary

Receiving inappropriate or unnecessary antibiotics for asymptomatic bacteriuria or urinary tract infections can lead to unnecessary side effects. In this multicenter, pre- and post-test study, we evaluate the effect of an antimicrobial stewardship initiative focusing on appropriate diagnosis and treatment of cystitis and pyelonephritis in patients seen at inpatient institutions in the emergency room. The primary endpoint is fluoroquinolone and oral third generation cephalosporin antibiotics use for lower urinary tract infections (UTIs) (per total antibiotics prescribed for lower UTIs). Secondary endpoints include appropriateness of empiric antibiotics for the treatment of pyelonephritis and cystitis and cases of asymptomatic bacteriuria treated with antibiotics per total cases of suspected UTIs.

Institution
Palmetto
Recruitment Contact
Hana Winders
803-777-1661
rac@cop.sc.edu

A Phase 3 Prospective, Randomized, Double-blinded, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Rebiotix RBX2660 (microbiota suspension) for the Prevention of Recurrent Clostridium difficile Infection Save

Date Added
March 13th, 2018
PRO Number
Pro00074072
Researcher
Scott Curry

List of Studies

Silhouette
Keywords
Digestive System, Infectious Diseases
Summary

A clinical study for people with recurrent Clostridium difficile infection (CDI), which is an infection in the intestines. This infection causes severe diarrhea. Recurrent Clostridium difficile (C. diff) infection is being studied as part of a medical research study for an investigational new drug called RBX2660, an enema made of a solution of stool (poop or feces).

Institution
MUSC
Recruitment Contact
Scott Curry
843-876-8646
currysr@musc.edu

Early Intrapleural TPA Instillation Versus Late (ELEVATE) Save

Date Added
February 17th, 2017
PRO Number
Pro00058518
Researcher
Rohan Arya

List of Studies

Keywords
Cancer/Lung, Drug Studies, Infectious Diseases, Lung, Pulmonary, Shortness of Breath
Summary

When a chest tube is placed, it can be hard for the fluid to drain. Tissue plasminogen activator and DNase are given through the chest tube to help with draining the fluid. We are doing this research to see if early addition of tPA-DNase will help with better fluid draining.

Institution
Palmetto
Recruitment Contact
Rohan Mankikar
803-352-1237
rohan.mankikar@palmettohealth.org

Change_preferences

-- OR --

Create_login