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NCT06794944 · ClinicalTrials.gov registry record · Phase 4
Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Not yet
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT06794944 is a Phase 4 study that has not yet begun recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 60 participants.
The verdict
NCT06794944, a Phase 4 study, has not yet begun recruiting, sponsored by Brigham and Women's Hospital.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a randomized, double-blind study to assess the safety and efficacy of fidaxomicin compared to vancomycin for decolonization of C. difficile in IBD patients. A total of 60 patients who meet eligibility criteria will be randomized 1:1 to either the fidaxomicin or vancomycin arm. The vancomycin arm will receive a dose of 125 mg PO q 6 hours for 10 days. The fidaxomicin arm will receive 200 mg PO BID for 10 days. In order to ensure blinding, both antibiotics will be concealed in opaque 00 capsule shells. In addition, those in the fidaxomicin arm will receive 2 placebo capsules so that all participants will receive 4 capsules daily for 10 days. Microbiome assessment and C. difficile testing will be performed at baseline, day 5, day 10, and weeks 4, 8, and 26.
Interventions
- DRUG Fidaxomicin
- DRUG Vancomycin (POC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-09 |
| Est. Completion | 2031-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06794944
The ClinicalTrials.gov registry entry for NCT06794944 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fidaxomicin is the first listed.
NCT06794944 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06794944 about?
NCT06794944 is a clinical study titled "Use of Fidaxomicin Compared to Vancomycin for Decolonization of C. Difficile in Patients With Inflammatory Bowel Disease". This is a randomized, double-blind study to assess the safety and efficacy of fidaxomicin compared to vancomycin for decolonization of C. difficile in IBD patients. A total of 60 patients who meet eligibility criteria will be randomized 1:1 to either the fidaxomicin or vancomycin arm. The vancomycin...
What is the current status of trial NCT06794944?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2026-09. Estimated completion is 2031-09.
What interventions are being tested in trial NCT06794944?
The interventions under investigation include: Fidaxomicin (DRUG), Vancomycin (POC) (DRUG).
Who is sponsoring clinical trial NCT06794944?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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