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

Phase 2

Terminated

• Conditions: Clostridium Difficile
• Interventions: Other: Placebo; Drug: Misoprostol 100Mcg Tab

• Registration Number: NCT03617172
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-06
• Study Start: 2018-11-26
• Primary Completion: 2021-09-22
• Study Completion: 2021-09-22
• Results First Submitted: 2022-08-24
• Status Verified: 2022-11
• Results First Submitted QC: 2022-11-10
• Last Update Submitted: 2022-11-10
• Results First Posted: 2022-11-30
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Study Drug (Misoprostol)	Misoprostol 100Mcg Tab	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Recurrence of Clostridium Difficile Infection (CDI).	8 weeks	Number of Participants with clinical recurrence of Clostridium Difficile Infection (CDI) in the 8 week follow-up period.

Secondary Outcome Measures

Name	Time	Method
Number of Recurrences During the Follow-up Period	8 weeks	Number of recurrences during the follow-up period (for those who have a first recurrence during the follow-up time period)
Time to Resolution of Diarrhea	8 weeks	Time to resolution of diarrhea (TTROD; for those with recurrence)

Trial Locations

Locations (3)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States