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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03617172
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
David Aronoff, 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 vancomycin 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 vancomycin 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).

Condition or disease Intervention/treatment Phase
Clostridium Difficile Drug: Misoprostol 100Mcg Tab Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial to Assess The Efficacy and Safety of Misoprostol in The Prevention of First Recurrence of Clostridium Difficile Infection in Adults Aged 50 and Over
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: Study Drug (Misoprostol) Drug: Misoprostol 100Mcg Tab
Two 100mcg capsules twice per day

Placebo Comparator: Placebo Other: Placebo
Two capsules twice per day




Primary Outcome Measures :
  1. Rate of clinical recurrence of CDI in patients aged 50 years or older during the first 8 weeks after vancomycin therapy is stopped. [ Time Frame: 8 weeks ]
    Rate of recurrence among misoprostol treated participants will be compared with that of placebo treated participants to determine if misoprostol has efficacy in preventing rCDI. rCDI will be defined as people who meet criteria for CDI in the 8 week follow-up period.


Secondary Outcome Measures :
  1. Number of recurrences during the follow-up period [ Time Frame: 8 weeks ]
    Number of recurrences during the follow-up period (for those who have a first recurrence during the follow-up time period)

  2. Time to resolution of diarrhea [ Time Frame: 8 weeks ]
    Time to resolution of diarrhea (TTROD; for those with recurrence)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Primary episode of CDI, defined as ALL of the following:

    1. ≥3 unformed (loose or watery) stools with a 24-hour period;
    2. 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
    3. No other explanation for diarrhea (e.g. laxatives).
  2. At the time of enrollment, on a course of oral vancomycin.
  3. Be ≥50 years of age and able to provide signed and dated informed consent.
  4. Must be able to read and understand English.

Exclusion Criteria

  1. Have had more than 1 episode of CDI within 6 months before the day of enrollment, as evidenced by self-reporting or EHR verification.
  2. Have not recovered from primary episode of CDI at time of enrollment, defined as presence of ALL of the following:

    1. ≥3 unformed (loose or watery) stools per day for at least 2 consecutive days prior to and continuing to the time of randomization, and
    2. Abdominal discomfort must be absent or mild for at least 2 consecutive days prior to and continuing to the time of randomization.
  3. Have received, or plans to use, any of the following for treatment of the primary episode of CDI:

    1. Any immunotherapy (e.g., intravenous immunoglobulin, bezlotoxumab).
    2. Any toxin-binding therapy (e.g., cholestyramine [Questran], colestipol [Colestid], or colesevelam [Welchol]).
  4. Current or planned treatment with prostanoid therapy.
  5. Diarrhea caused by another infection or underlying gastrointestinal disorder.
  6. Have an acute febrile illness (fever >38°C [100.4°F]) on the day prior to the first dose of study drug.
  7. Plan to receive an oral or parenteral (e.g., intravenous, intramuscular, or intraperitoneal) antibacterial therapy after randomization.
  8. Have any contraindication to oral/enteral therapy (e.g., severe nausea/vomiting or ileus).
  9. Have an absolute neutrophil count <1000/mm3 [1.0 x 109/L] within 90 days of screening.
  10. Myocardial infarction within the past 6 months of enrollment.
  11. Have a known immunodeficiency disorder, including but not limited to:

    1. HIV infection with CD4 count <200 or CD4 count of any level and not on highly active antiretroviral therapy
    2. Receiving, or plans to receive, treatment with systemic corticosteroids.
    3. Receiving, or plans to receive, myelosuppressive cancer chemotherapy.
  12. Require or have an anticipated need for mechanical ventilation or vasopressors for hemodynamic support during the study.
  13. Pregnant, nursing, or planning to become pregnant.
  14. Have taken investigational drugs within 30 days before misoprostol administration.
  15. Inability to understand the requirements of the study, inability to abide by the study restrictions and to return for the required treatments and assessments.
  16. 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.
  17. Known hypersensitivity to misoprostol.
  18. Be unwilling or unable to follow study procedures (e.g., study visits, swallow the study drug/placebo, provide stool samples and undergo phlebotomy according to the study schedule, and reliably report information by phone), or not have a caregiver who can ensure that study procedures are followed.
  19. If female, be pre-menopausal (cessation of menses less than or equal to 1 year) and not surgically sterile or not following acceptable non-hormonal method of birth control such as abstinence, intrauterine device, or barrier control for at least 1 complete menstrual cycle before the screening visit, or using estrogen/progestin containing products for at least 2 months before the screening visit through discharge from the study.
  20. Not have reliable access to telephone service to allow for contact with study personnel.
  21. Be unable to be seen for routine clinical care either as an outpatient or inpatient at one of the three study sites.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617172


Contacts
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Contact: David M Aronoff, M.D. 615-343-8010 d.aronoff@vumc.org

Locations
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United States, Missouri
Washington University Not yet recruiting
Saint Louis, Missouri, United States, 63130
Contact: Erik Dubberke, M.D.    314-454-8293    edubberk@wustl.edu   
United States, North Carolina
University of North Carolina Not yet recruiting
Chapel Hill, North Carolina, United States, 27514
Contact: Sarah McGill, M.D.    919-966-8929    mcgills@email.unc.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: David M Aronoff, MD    615-343-8010    d.aronoff@vumc.org   
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institutes of Health (NIH)

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Responsible Party: David Aronoff, Director, Division of Infectious Diseases, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03617172     History of Changes
Other Study ID Numbers: 172163
U01TR002398 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Recurrence
Disease Attributes
Pathologic Processes
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics