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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 is a Phase 2 study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 6 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03617172
The ClinicalTrials.gov registry entry for NCT03617172 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03617172 reports 0 study locations.
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.
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