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NCT00177970 · ClinicalTrials.gov registry record · Phase 4
IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff
A Phase 4 study, sponsored by University of Pittsburgh.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT00177970 is a Phase 4 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 14 participants.
The verdict
NCT00177970, a Phase 4 study, was terminated before completion, sponsored by University of Pittsburgh.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG intravenous immunoglobulin G (IVIG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2003-10 |
| Est. Completion | 2008-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00177970
The ClinicalTrials.gov registry entry for NCT00177970 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00177970 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00177970 about?
NCT00177970 is a clinical study titled "IVIG Versus Placebo for the Treatment of Patients With Severe C-Diff". 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 Shadysid...
What is the current status of trial NCT00177970?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2003-10. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00177970?
The interventions under investigation include: Placebo (DRUG), intravenous immunoglobulin G (IVIG) (DRUG).
Who is sponsoring clinical trial NCT00177970?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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