Early Intrapleural TPA Instillation Versus Late (ELEVATE) Save

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

The effect of early versus late urinary catheter removal on post-operative urinary retention (POUR) and catheter-associated urinary tract infection (CAUTI) rates in patients with POUR risk factors receiving thoracic epidural analgesia (TEA) for post-operative thoracic surgery pain control Save

Date Added
November 15th, 2016
PRO Number
Pro00058458
Researcher
Michaella Prasad
Keywords
Bladder, Infectious Diseases, Pain, Spinal Cord, Surgery, Urinary
Summary

Patients scheduled for thoracic surgery will be identified as potential candidates and recruited by a research coordinator before surgery. Research subjects will be randomized to either early or late post-operative urinary catheter (a thin flexible tube placed into the bladder to drain urine) removal. Thoracic epidural analgesia (TEA), a thin tube placed near the spinal cord, will remain functioning after urinary catheter removal for the early group. The study group randomized to early catheter removal will have urinary catheters removed 24 hours after surgery is completed. Study subjects that are randomized to late removal of urinary catheter will have urinary catheters removed after TEA is discontinued as routine clinical care (usually 4-5 days). Determination of bladder urine volume will be made by sound wave examination (ultrasound) by appropriately-trained staff. Following indwelling urinary catheter removal, research subjects may receive a brief urine drain tube as standard clinical care. Laboratory urine analysis will be obtained from urine following removal of urinary catheter and assessed for urinary tract infection (UTI).

Institution
MUSC
Recruitment Contact
Bill Rawls
9196360725
rawlsw@musc.edu

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
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

A Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous (IV) and Powder for Oral Suspension Formulations of Posaconazole (POS) in Immunocompromised Pediatric Subjects with Neutropenia Save

Date Added
August 23rd, 2016
PRO Number
Pro00057337
Researcher
Jacqueline Kraveka
Keywords
Cancer, Infectious Diseases, Pediatrics
Summary

The intention of this study is to collect the laboratory data, safety, and tolerability information on Posaconazole (POS) administered through IV and oral solution to neutropenic pediatric subjects, or pediatric subjects who are expected to become neutropenic , and who are at risk of developing Invasive Fungal Infections (IFI). The subjects will range in age from 2 years to 17 years of age. This age range represents the pediatric population at risk of developing IFI for which data are lacking. The study design includes an assessment of safety for all treated subjects at each dose level for each age group employing rapid data collection and centralized analysis.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu

Bronchiectasis and Nontuberculous Mycobacterium Patient Registry Save

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

A DOUBLE BLIND, RANDOMIZED, STRATIFIED, MULTI-CENTER TRIAL EVALUATING CONVENTIONAL AND DOUBLE DOSE OSELTAMIVIR IN THE TREATMENT OF IMMUNOCOMPROMISED PATIENTS WITH INFLUENZA Save

Date Added
October 27th, 2015
PRO Number
Pro00047307
Researcher
Andrew Atz
Keywords
Disease Prevention, Drug Studies, Immune System, Infectious Diseases, Pediatrics
Summary

The purpose of this study is to test the safety and efficacy of oseltamivir (Tamiflu) for the treatment of influenza in immunocompromised patients.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

Temporal impact of broad-spectrum, empirical antibiotic therapy on host microbiome in hospitalized patients Save

Date Added
October 19th, 2015
PRO Number
Pro00048239
Researcher
Rachel Foster
Keywords
Infectious Diseases, Non-interventional
Summary

This pilot study is designed as a preliminary study to determine if a significant difference exists in the stool bacterial diversity of hospitalized patients on broad-spectrum antibiotics during different points in their course of therapy. Fecal samples will be collected from study subjects at pre-defined time intervals (baseline, >48 to 96 to 144 to <192 hours) during their course of antibiotic therapy. Stool samples will be analyzed for the number and abundance (diversity) of bacterial species present.

Institution
Palmetto
Recruitment Contact
Rachel Foster
(803) 434-2925
fosterr8@sccp.sc.edu

Incisional negative pressure wound therapy for preoperatively irradiated lower extremity soft tissue sarcoma wounds. A prospective randomized clinical trial. Save

Date Added
August 18th, 2015
PRO Number
Pro00028423
Researcher
Lee Leddy
Keywords
Cancer, Cancer/Sarcoma, Infectious Diseases
Summary

This is a study comparing two methods of dressing a post operative wound that are currently in practice. One method is a traditional dry gauze dressing. The other method is using a negative pressure dressing that provides gentle suction on the wound.

We will attempt to determine how well the use of post-operative negative pressure dressing reduces wound healing problems in patients who have surgery after radiation for a sarcoma in the thigh or leg.

Institution
MUSC
Recruitment Contact
Jennifer Philp
843 8462210
Philp, Jennifer (philpj@musc.edu)

Elucidating Mechanisms of Treatment Relapse for Interferon-Free HCV Therapy Save

Date Added
August 18th, 2015
PRO Number
Pro00046669
Researcher
Eric Meissner
Keywords
Digestive System, HIV / AIDS, Immune System, Infectious Diseases, Liver
Summary

Treatment of chronic hepatitis C virus (HCV) infection is now possible with all oral medications. While most patients achieve a sustained virologic response (SVR) after treatment, synonymous with cure, some patients relapse after treatment for reasons that are unclear. The goal of this research is to understand how a person's immune system changes during treatment of HCV infection with all oral therapy, and how these changes might impact the chances of relapse after treatment. To address these questions, blood and clinical information will be collected from study participants over the course of receiving standard of care treatment for HCV infection. This blood and clinical information will be used to conduct laboratory research focused on the immune system.

Institution
MUSC
Recruitment Contact
Stephanie Warth
843-792-5491
warth@musc.edu

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