Clinical Trials Directory

Trials / Terminated

TerminatedNCT03617172

PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol

A Randomized, Double-Blind, Placebo-Controlled Trial to Assess The Efficacy and Safety of Misoprostol in The Prevention of Recurrence of Clostridium Difficile Infection in Adults

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
6 (actual)
Sponsor
Vanderbilt University Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGMisoprostol 100Mcg TabTwo 100mcg capsules twice per day
OTHERPlaceboTwo capsules twice per day

Timeline

Start date
2018-11-26
Primary completion
2021-09-22
Completion
2021-09-22
First posted
2018-08-06
Last updated
2022-11-30
Results posted
2022-11-30

Locations

3 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03617172. Inclusion in this directory is not an endorsement.