NCT00177970

IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff

Intravenous Immunoglobulin G Versus Placebo for the Treatment of Patients With Severe Clostridium Difficile-Associated Diarrhea and Colitis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

See "Brief Summary" for details

Conditions

• Clostridium Difficile-associated Diarrhea (CDAD)

Interventions

Type	Name	Description
DRUG	intravenous immunoglobulin G (IVIG)	IVIG to be given IV to patients with C-Diff .
DRUG	Placebo	Placebo to be given IV to patients with C-Diff

Timeline

• Start date: 2003-10-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2005-09-15
• Last updated: 2016-10-25
• Results posted: 2016-07-15

Locations

4 sites across 1 country: United States