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NCT03617172 · ClinicalTrials.gov registry record · Phase 2
PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol
A Phase 2 study, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT03617172: Clinical Trial Phase 2 study, sponsored by Vanderbilt University Medical Center.
NCT03617172 is a Phase 2 study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03617172, a Phase 2 study, was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
A total of 440 patients meeting enrollment criteria with a primary episode of C. Difficile Infection (CDI) will be enrolled across 3 sites. The total study time period for study procedures followed by clinical monitoring is anticipated to be about 24 months (biomarker assays and other analyses may be completed after the 24 month time period). All participants will receive oral antibiotics for CDI under the care of their physician. After consenting to participate in the study, participants will be randomized to receive either misoprostol (200 mcg po BID) or matching placebo for 14 days. Participants will be monitored for a total time-period of approximately 9 weeks with the goal of monitoring for recurrence of CDI during an 8-week follow-up period from the time that the course of antibiotic treatment is completed. Patients will have blood and stool samples (or rectal swabs if participants are unable to provide a stool sample) collected throughout the study to assess adherence, biomarkers, and to confirm recurrence of CDI (if necessary).
Primary Outcome
Number of Participants with clinical recurrence of Clostridium Difficile Infection (CDI) in the 8 week follow-up period.
Interventions
- OTHER Placebo
- DRUG Misoprostol 100Mcg Tab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-11-26 |
| Est. Completion | 2021-09-22 |
| Phase | Phase 2 |
Why NCT03617172 stopped before completion
NCT03617172 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03617172 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03617172 about?
NCT03617172 is a clinical study titled "PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol". A total of 440 patients meeting enrollment criteria with a primary episode of C. Difficile Infection (CDI) will be enrolled across 3 sites. The total study time period for study procedures followed by clinical monitoring is anticipated to be about 24 months (biomarker assays and other analyses may b...
What is the current status of trial NCT03617172?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2018-11-26. Estimated completion is 2021-09-22.
What interventions are being tested in trial NCT03617172?
The interventions under investigation include: Placebo (OTHER), Misoprostol 100Mcg Tab (DRUG).
Who is sponsoring clinical trial NCT03617172?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03617172's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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