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

NCT03617172 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 172163U01TR002398
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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).

Conditions

Clostridium Difficile

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Recurrence of Clostridium Difficile Infection (CDI).

  Number of Participants with clinical recurrence of Clostridium Difficile Infection (CDI) in the 8 week follow-up period.

  8 weeks

Secondary Outcomes (2)

• Number of Recurrences During the Follow-up Period

  8 weeks

• Time to Resolution of Diarrhea

  8 weeks

Study Arms (2)

Study Drug (Misoprostol)

EXPERIMENTAL

Drug: Misoprostol 100Mcg Tab

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Misoprostol 100Mcg Tab DRUG

Two 100mcg capsules twice per day

Study Drug (Misoprostol)

Placebo OTHER

Two capsules twice per day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Episode of CDI, defined as ALL of the following:
• ≥3 unformed (loose or watery) stools with a 24-hour period;
• A documented positive C. difficile toxin assay (enzyme immunoassay \[EIA\] or cell cytotoxicity assay) or NAAT for toxigenic C. difficile from a stool sample collected while the subject was symptomatic; and
• No other explanation for diarrhea (e.g. laxatives).
• At the time of enrollment, on a course of oral antibiotics commonly used for treatment of CDI.
• Be ≥18 years of age.
• Be able to provide signed and dated informed consent.
• Must be able to read and understand English.

You may not qualify if:

• Have not recovered from primary episode of CDI at time of enrollment, defined as presence of EITHER of the following:
• ≥3 unformed (loose or watery) stools during the 24 hours prior to randomization, OR
• Abdominal discomfort (more than mild) present during the 24 hours prior to randomization.
• Have received, or plans to use, any of the following for treatment of the primary episode of CDI:
• Any immunotherapy (e.g., intravenous immunoglobulin, bezlotoxumab).
• Any toxin-binding therapy (e.g., cholestyramine \[Questran\], colestipol \[Colestid\], or colesevelam \[Welchol\]).
• Current or planned treatment with prostanoid therapy.
• Diarrhea caused by another infection or diarrhea caused by an underlying gastrointestinal disorder.
• Have any contraindication to oral/enteral therapy (e.g., severe nausa/vomiting or ileus).
• Have an absolute neutrophil count \<500/mm3 \[1.0 x 109/L\] within 30 days of screening.
• Require or have an anticipated need for mechanical ventilation or vasopressors for hemodynamic support during the study.
• Pregnant, nursing, or planning to become pregnant.
• Inability to understand the requirements of the study, inability to abide by the study restrictions.
• Have any clinically significant medical or surgical condition that in the investigator's opinion could interfere with the administration of study drug, interpretation of study results, or compromise the safety or well-being of the subject.
• Known hypersensitivity to misoprostol.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institutes of Health (NIH): collaborator

Study Sites (3)

Washington University

St Louis, Missouri, 63130, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Sr. Clinical Trials Operations Manager
• Organization: Vanderbilt University Medical Center

stephanie.anne.smith@vumc.org

6159360815

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Department of Medicine, Division of Infectious Diseases

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 6, 2018
• Study Start: November 26, 2018
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: November 30, 2022
• Results First Posted: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)