Clostridium DifficilePhase 2PROCLAIMNCT03617172
PROCLAIM -- Misoprostol in the Prevention of Recurrent CDI Prevent Recurrence of Clostridium Difficile Infection With Misoprostol
A Phase 2 study testing Misoprostol 100Mcg Tab in people with Clostridium Difficile, run by Vanderbilt University Medical Center at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Misoprostol 100Mcg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Nov 2018to 22 Sep 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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]).
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- 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.
- 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.
- If female, be pre-menopausal (cessation of menses less than or equal to 1 year) and not surgically/medically 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 not using estrogen/progestin containing products for at least 2 months before the screening visit through discharge from the study.
- Unreliable access to telephone service to allow for contact with study personnel.
- Inability to be seen for routine clinical care either as an outpatient or inpatient.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina
Chapel Hill, North Carolina, 27514
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Washington University
St Louis, Missouri, 63130
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial to Assess The Efficacy and Safety of Misoprostol in The Prevention of Recurrence of Clostridium Difficile Infection in Adults
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
- Being tested
- Misoprostol 100Mcg Tab, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 100Mcg TabDrug
Two 100mcg capsules twice per day
PlaceboOther
Two capsules twice per day
| Study group | Role | What they receive |
|---|---|---|
| Study Drug (Misoprostol) | Experimental | Not described Receives: Drug: Misoprostol 100Mcg Tab |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
Number of Recurrences During the Follow-up Period
Number of recurrences during the follow-up period (for those who have a first recurrence during the follow-up time period)
Measured: 8 weeks
Time to Resolution of Diarrhea
Time to resolution of diarrhea (TTROD; for those with recurrence)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start26 Nov 2018
- Primary completion22 Sep 2021
- Study completion22 Sep 2021
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridium DifficileStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Ryan S. Doster, MD, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617172
- Sponsor's protocol ID
- 172163
- Other IDs
- U01TR002398
- Acronym
- PROCLAIM
- Status last verified
- Nov 2022
- First submitted
- 1 Aug 2018
- Last updated
- 30 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial to Assess The Efficacy and Safety of Misoprostol in The Prevention of Recurrence of Clostridium Difficile Infection in Adults
- ClinicalTrials.gov ID
- NCT03617172
- Acronym / sponsor ID
- PROCLAIM / 172163
- Conditions
- Clostridium Difficile
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 22 Sep 2021 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Posted 30 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Drug (Misoprostol) | Experimental | Drug: Misoprostol 100Mcg Tab |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Episode of CDI, defined as ALL of the following:
- 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.
Key exclusion criteria (19 listed)
- Have not recovered from primary episode of CDI at time of enrollment, defined as presence of EITHER of the following:
- Have received, or plans to use, any of the following for treatment of the primary episode of CDI:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Misoprostol 100Mcg TabTwo 100mcg capsules twice per day | Drug | Study Drug (Misoprostol) |
| PlaceboTwo capsules twice per day | Other | Placebo |
Primary outcome
Number of Participants With Clinical Recurrence of Clostridium Difficile Infection (CDI).
Time frame: 8 weeks
Number of Participants with clinical recurrence of Clostridium Difficile Infection (CDI) in the 8 week follow-up period.
2 secondary outcomes
Number of Recurrences During the Follow-up Period
Time frame: 8 weeks
Time to Resolution of Diarrhea
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Clostridium Difficile
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Clostridioides Difficile Infection
Active, not recruitingPhase 2
Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Hematopoietic Stem Cell
RecruitingPhase 3
A Study to Learn About a Clostridioides Difficile Vaccine in People 65 Years of Age and Older
Clostridoides Difficile Associated Disease
Active, not recruitingObservational study
C. Difficile Toxin Levels in Stool From Healthy Individuals Following Standard of Care Antibiotic Treatment for CDI.
Clostridioides Difficile Infection Recurrence
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Misoprostol 100Mcg Tab in people with Clostridium Difficile, run by Vanderbilt University Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinical Recurrence of Clostridium Difficile Infection (CDI). (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.