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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: Clinical Trial Phase 4 study, sponsored by Brigham and Women's Hospital.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Absence of C. difficile via PCR in Week 8 stool sample
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 |
What is known before NCT06794944 opens enrollment
NCT06794944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Fidaxomicin is the first listed.
NCT06794944 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06794944's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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