Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177970
Status:
TERMINATED
Last Update Posted:
2016-10-25
First Post:
2005-09-13
Brief Title:
IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Intravenous Immunoglobulin G Versus Placebo for the Treatment of Patients With Severe Clostridium Difficile-Associated Diarrhea and Colitis
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
We were unable to receive IVIG free from phamaceutical company
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this trial eligible patients will be randomly assigned to receive a single dose of 400 mgkg 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 Margarets 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None