Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Kevin Winthrop.
NCT03672630 is a Phase 2 study that has completed, run by Kevin Winthrop. The registered enrollment target is 474 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (256% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Two consecutive negative AFB cultures by 12 months post randomization without reversion to positive
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 |
What the finished NCT03672630 record still lists
NCT03672630 is an interventional study that assigns participants to a tested intervention. The registered 474 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (256% higher).
The record links to 0 conditions, and to 3 interventions - of which Azithromycin is the first listed.
NCT03672630 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03672630's enrollment target sits among peer trials
474 77th of 2000 higher than 1,923 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05624996 · 474 participants · Phase 3
Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer
- NCT06051695 · 474 participants · Phase 1
A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
- NCT06632977 · 474 participants · Phase 2
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
- NCT01788839 · 475 participants
Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI