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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04186247
The ClinicalTrials.gov registry entry for NCT04186247 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Standard of Care is the first listed.
NCT04186247 reports 0 study locations.
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.
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