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Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease
Not Recruiting
Trial ID: NCT03672630
Purpose
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.
Official Title
Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease
Stanford Investigator(s)
Stephen Ruoss
Professor of Medicine (Pulmonary and Critical Care)
Eligibility
Inclusion Criteria:
- Culture positive pulmonary MAC meeting ATS/IDSA disease criteria
- Age over 18 years
- Ability to provide informed consent
Exclusion Criteria:
- Fibrocavitary disease
- Planned surgery for MAC disease
- Patients who have cumulatively taken 6 weeks or more of multi-drug antimicrobial
treatment for MAC
- Patients who are currently taking or have taken multi-drug antimicrobial treatment for
NTM within the prior 30 days
- Diagnosis of Cystic fibrosis
- Diagnosis of HIV
- History of solid organ or hematologic transplant
- Significant drug-drug interaction not clinically manageable in the opinion of the
investigator
- Contraindication to any component of the study treatment regimen
Intervention(s):
drug: Azithromycin
drug: Ethambutol
drug: Rifampin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305