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NCT03672630 · ClinicalTrials.gov registry record · Phase 2
Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease
A Phase 2 study, sponsored by Kevin Winthrop.
- Completed
- Registry status
- Phase 2
- Development phase
- 474
- Enrollment target
NCT03672630 is a Phase 2 study that has completed, run by Kevin Winthrop. The registered enrollment target is 474 participants.
The verdict
NCT03672630, a Phase 2 study, has completed, sponsored by Kevin Winthrop.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 474 participants
- Enrollment target
Study Summary
NTM therapy consists of a multi-drug macrolide based regimen for 18-24 months. Treated patients frequently experience debilitating side effects, and many patients delay the start of antibiotic treatment due to these risks. Common side effects include nausea, diarrhea, and fatigue, and rare but serious toxicities include ocular toxicity, hearing loss, and hematologic toxicity. To date, most of the evidence underlying the current treatment recommendations has come from observational studies in which either a macrolide has been combined with rifampin and ethambutol, or in some cases combined with ethambutol alone. The proposed study will answer whether a third drug is necessary or whether taking two drugs can increase tolerability without a substantial loss of efficacy.
Interventions
- DRUG Azithromycin
- DRUG Ethambutol
- DRUG Rifampin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 474 participants |
| Start Date | 2019-02-22 |
| Est. Completion | 2026-01-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03672630
The ClinicalTrials.gov registry entry for NCT03672630 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 474 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kevin Winthrop, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Azithromycin is the first listed.
NCT03672630 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03672630 about?
NCT03672630 is a clinical study titled "Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease". NTM therapy consists of a multi-drug macrolide based regimen for 18-24 months. Treated patients frequently experience debilitating side effects, and many patients delay the start of antibiotic treatment due to these risks. Common side effects include nausea, diarrhea, and fatigue, and rare but serio...
What is the current status of trial NCT03672630?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 474 participants. The study started on 2019-02-22. Estimated completion is 2026-01-08.
What interventions are being tested in trial NCT03672630?
The interventions under investigation include: Azithromycin (DRUG), Ethambutol (DRUG), Rifampin (DRUG).
Who is sponsoring clinical trial NCT03672630?
This trial is sponsored by Kevin Winthrop, which has 5 total clinical trials registered on ClinicalTrials.gov.
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