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

NCT03617172 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-11-30

Study results available
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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

  • Clostridium Difficile

Interventions

DRUG

Misoprostol 100Mcg Tab

Two 100mcg capsules twice per day

OTHER

Placebo

Two capsules twice per day

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Vanderbilt University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-26
Primary Completion
2021-09-22
Completion
2021-09-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03617172 on ClinicalTrials.gov