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

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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
8437921213
choudhar@musc.edu

A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (microbiota suspension) in Subjects with Recurrent Clostridium difficile Infection Save

Date Added
September 10th, 2019
PRO Number
Pro00089814
Researcher
Scott Curry

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Keywords
Digestive System, Infectious Diseases
Summary

An open-label clinical study in which all subjects will receive the same investigational drug, 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

Therapeutic Drug Monitoring of Beta-lactam Antibiotics Among Hospitalized Patients: A Pilot Study Save

Date Added
September 9th, 2019
PRO Number
Pro00086047
Researcher
P. brandon Bookstaver

List of Studies

Keywords
Infectious Diseases
Summary

Intravenous beta-lactams are used in over 14 million patients annually. Many of these patients, especially those who are critically ill, obese or are renally impaired have altered pharmacokinetics that may impact drug exposure. The inability to monitor serum concentrations routinely of these antibiotics limits our knowledge of appropriate dosing and may impact clinical outcomes. This project will be a pilot collaboration between Prisma Health Midlands Richland and the University of South Carolina to determine feasibility of a local TDM protocol. We will obtain two blood samples from 10 patients hospitalized currently receiving one of the target agents (ceftriaxone, cefepime or piperacillin/tazobactam) and with positive cultures. These data will be research use only as part of the pilot evaluation and will not be used for clinical decision making.

Institution
Palmetto
Recruitment Contact
Jeannette Bouchard
8034342925
jbouchar@cop.sc.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
8437921213
choudhar@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

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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

Retrospective Analysis of Hepatitis C Cure Rates in Family Medicine Clinic Save

Date Added
May 15th, 2019
PRO Number
Pro00088552
Researcher
Morgan Adams

List of Studies

Keywords
Infectious Diseases
Summary

Hepatitis C is the most common form of hepatitis in the United States. With the prevalence on the rise, it is important to consider utilizing more accessible healthcare providers to provide patient care for these patients. Due to the evolution of hepatitis C medications and the cure rates proving almost 100% cure, we believe that utilizing these providers is an appropriate option for care.

Caring for patients with hepatitis C has been integrated into the Palmetto Health-USC Family Medicine resident curriculum since 2017 to help residents gain exposure to treating the disease during residency. To date, the treatment success rate for resident primary care providers has not been studied.

Institution
Palmetto
Recruitment Contact
Morgan Adams
8034342072
morgan.adams@uscmed.sc.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

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

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