Clostridium Difficile-associated Diarrhea (CDAD) Clinical Trial
Official title:
Intravenous Immunoglobulin G Versus Placebo for the Treatment of Patients With Severe Clostridium Difficile-Associated Diarrhea and Colitis
In this trial, eligible patients will be randomly assigned to receive a single dose of 400
mg/kg of IVIG or a normal saline infusion as placebo over 4-6 hours, in addition to their
usual medications for CDAD. We expect to enroll approximately 40 patients over a period of
two years from UPMC Shadyside Hospital, McKeesport Hospital, and St. Margaret's Hospital who
are unresponsive to standard antimicrobial therapy for CDAD.
During the course of this study we expect that IVIG group compared with placebo group will
have fewer number of stools per day (< 3 per day). Secondary endpoints will include normal
WBC count, normal body temperature, 75% reduction in abdominal pain / tenderness, and
decrease in length of hospital stay.
Subjects will sign a written informed consent prior to any study procedures. Patients will
be monitored closely during the infusion of the study medication and will continue to be
monitored on a daily basis up to the time of discharge. Data collection will include vital
signs, CBC, stool C. difficile cytotoxin assay, and stool counts before and after therapy.
See "Brief Summary" for details ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01691248 -
Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001)
|
Phase 3 | |
Completed |
NCT02218372 -
A Study to Investigate the Safety and Efficacy of Fidaxomicin (Oral Suspension or Tablets) and Vancomycin (Oral Liquid or Capsules) in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD)
|
Phase 3 |