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

PHASE 2 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

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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 10 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

A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching From a Regimen of Two Nucleos(t)ide Reverse Transcriptase Inhibitors (NRTI) plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants Save

Date Added
October 5th, 2018
PRO Number
Pro00081856
Researcher
Helmut Albrecht

List of Studies

Keywords
Drug Studies, HIV / AIDS, Infectious Diseases
Summary

The primary objective of this study is to evaluate the efficacy of switching from a regimen of 2 nucleos(t)ide reverse transcriptase inhibitors (NRTIs) and a third agent to a fixed dose combination (FDC) of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing their baseline regimen in HIV-1 infected, virologically suppressed African American participants.

Institution
Palmetto
Recruitment Contact
Helmut Albrecht
803-540-1000
ClinicalTrialSurvey@PalmettoHealth.org

Impact of an Emergency Room Urinary Tract Antimicrobial Stewardship Intervention Save

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

List of Studies

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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 Rac
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

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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

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients with Cytomegalovirus (CMV) Infections that are Refractory or Resistant to Treatment with Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir. Save

Date Added
November 8th, 2016
PRO Number
Pro00058351
Researcher
Vinayak Rohan

List of Studies

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Keywords
Drug Studies, Infectious Diseases, Transplant
Summary

This study is for patients who have received a kidney, liver, or pancreas transplant and who have developed resistant Cytomegalovirus infection. There will be two treatment groups to compare the improvement or resolution of Cytomegalovirus infection. Subjects will be randomized to receive 8 weeks of either the investigational drug, Maribavir, or physician assigned standard of care treatment.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7558
schaffne@musc.edu

Bronchiectasis and Nontuberculous Mycobacterium Patient Registry Save

Date Added
November 19th, 2015
PRO Number
Pro00045254
Researcher
Patrick Flume

List of Studies


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Keywords
Infectious Diseases, Lung, Pulmonary
Summary

Non-cystic fibrosis (CF) bronchiectasis is a lung disease characterized by dilation of the airways. Patients often suffer from chronic airways infection. One such associated infection is non-tuberculosis mycobacterium (NTM) lung disease, which is 50 to 75 times more common in patients with bronchiectasis than those without it. The decision to initiate treatment (for NTM pulmonary disease) is not straightforward, hinging on how the patient feels and excluding other causes for their symptoms. Symptoms patients frequently report are pulmonary related (e.g. cough, sputum production, and coughing up blood) and constitutional symptoms (e.g. fevers, weight loss and body aches). When treatment is started for NTM lung disease, it can be for many months to years and has many potential side effects. The scientific literature rarely reports outcomes of treatment from a patient's perspective, which could aid a physician's decision to initiate treatment and/or response to treatment of the patient's NTM disease. This study will 1) create a Patient Registry for patients with bronchiectasis and/or NTM disease with an emphasis on patient reported outcomes (PRO) using questionnaires and 2) prospectively collect and analyze the clinical data for patients seen in the MUSC Bronchiectasis and/or NTM clinic

Institution
MUSC
Recruitment Contact
Amy Chamberlain
843-792-3162
chambeam@musc.edu

Immune response to pneumococcal vaccination in aging HIV positive adults Save

Date Added
November 17th, 2015
PRO Number
Pro00046749
Researcher
Maria anna Westerink

List of Studies

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Keywords
Aging, Blood Disorders, Healthy Volunteer Studies, HIV / AIDS, Infectious Diseases, Vaccine
Summary

We are doing this study to find out what practice, one dose PPV23 or one dose PCV13 followed by one dose PPV23, protects better against pneumonia in older HIV-positive.

Institution
MUSC
Recruitment Contact
Myroslawa Soloshchenko
8437922218
soloshch@musc.edu

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