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NCT02667418 · ClinicalTrials.gov registry record · Phase 4
Optimal Treatment for Recurrent Clostridium Difficile
A Phase 4 study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- Phase 4
- Development phase
- 308
- Enrollment target
NCT02667418: Clinical Trial Phase 4 study, sponsored by VA Office of Research and Development.
NCT02667418 is a Phase 4 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 308 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02667418, a Phase 4 study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 308 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile infection.
Primary Outcome
The Primary outcome will be sustained clinical response as measured at study day 59 for all treatment regimens. Sustained clinical response is a composite outcome that includes symptom resolution during treatment without any of the following (as assessed on day 59): 1. Diarrhea recurrence 2. Other non-fatal clinical events including severe abdominal pain, toxic megacolon (where diarrhea ceases but is not a beneficial outcome), and colectomy 3. Death
Interventions
- DRUG Vancomycin
- DRUG Fidaxomicin
- DRUG Vancomycin with Taper/Pulse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2016-02-19 |
| Est. Completion | 2024-08-31 |
| Phase | Phase 4 |
Why NCT02667418 stopped before completion
NCT02667418 is an interventional study that assigns participants to a tested intervention. The registered 308 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (41% lower).
The record links to 0 conditions, and to 3 interventions - of which Vancomycin is the first listed.
NCT02667418 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02667418 about?
NCT02667418 is a clinical study titled "Optimal Treatment for Recurrent Clostridium Difficile". The purpose of this study is to determine whether fidaxomicin and vancomycin followed by taper and pulse vancomycin treatment are superior to standard vancomycin treatment for the treatment of recurrent Clostridium difficile infection.
What is the current status of trial NCT02667418?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 308 participants. The study started on 2016-02-19. Estimated completion is 2024-08-31.
What interventions are being tested in trial NCT02667418?
The interventions under investigation include: Vancomycin (DRUG), Fidaxomicin (DRUG), Vancomycin with Taper/Pulse (DRUG).
Who is sponsoring clinical trial NCT02667418?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02667418's enrollment target sits among peer trials
308 263rd of 2000 higher than 1,738 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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