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NCT04186247 · ClinicalTrials.gov registry record · Phase 2
Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT04186247: Clinical Trial Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT04186247 is a Phase 2 study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04186247, a Phase 2 study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, controlled open-label add-on design trial pilot study to evaluate the efficacy of personalized adjunctive antibiotic (azithromycin + metronidazole) therapy in pediatric subjects with mild to moderate Crohn's disease (CD) who have a microbiome profile associated with increased risk of early relapse. This an add-on design trial for subjects already receiving standard of care therapy to induce remission; there will be no placebos.
Primary Outcome
Participants stratified based on carriage of an at-risk microbiome without need for re-induction for clinical flare (new course of nutritional therapy, need to restart steroids), steroid dependence, biologic (e.g. anti-TNF) use, and/or intestinal surgery.
Interventions
- OTHER Standard of Care
- DRUG Azithromycin
- DRUG Metronidazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-08-13 |
| Est. Completion | 2023-12-31 |
| Phase | Phase 2 |
Why NCT04186247 stopped before completion
NCT04186247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Standard of Care is the first listed.
NCT04186247 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04186247 about?
NCT04186247 is a clinical study titled "Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)". This is a multi-center, randomized, controlled open-label add-on design trial pilot study to evaluate the efficacy of personalized adjunctive antibiotic (azithromycin + metronidazole) therapy in pediatric subjects with mild to moderate Crohn's disease (CD) who have a microbiome profile associated wi...
What is the current status of trial NCT04186247?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2021-08-13. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT04186247?
The interventions under investigation include: Standard of Care (OTHER), Azithromycin (DRUG), Metronidazole (DRUG).
Who is sponsoring clinical trial NCT04186247?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04186247's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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