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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: Clinical Trial Phase 4 study, sponsored by University of Pittsburgh.
NCT00177970 is a Phase 4 study that was terminated before completion, run by University of Pittsburgh. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
During the course of the study, we expect the IVIG group compared to the placebo group will have a normal WBC count 3.8-10.0/CMM
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 |
Why NCT00177970 stopped before completion
NCT00177970 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00177970 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00177970's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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