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

Age Range:50 - Any
Start Date:November 26, 2018
End Date:November 2024
Contact:David M Aronoff, M.D.

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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

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).

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

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

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

21. Be unable to be seen for routine clinical care either as an outpatient or inpatient at
one of the three study sites.
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