Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:February 22, 2019
End Date:February 28, 2023
Contact:Andie Hendrick
Email:hendrmic@ohsu.edu
Phone:503-494-2136

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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.

Mycobacterium avium complex (MAC) are a subset of nontuberculous mycobacteria (NTM),
environmental bacteria that can cause chronic, debilitating pulmonary disease, primarily
affecting those over age 60. The goals of treatment are to improve symptoms, stop disease
progression, and clear the infection. We propose to address a longstanding controversy in the
therapy of pulmonary MAC disease, whether patients must take three antibiotics concomitantly,
or if two are sufficient. The study is a multicenter randomized pragmatic clinical trial to
compare azithromycin + ethambutol (2-drug therapy) vs. azithromycin + ethambutol + rifampin
(3-drug therapy) for non-cavitary pulmonary MAC disease. All clinical outcomes will be
considered standard of care and abstracted from clinical records. Therapy changes and adverse
events will be recorded at routine visits. Health-related quality of life (HRQoL) and
self-reported toxicity will be captured centrally in a web-based database, and CT scans will
be read centrally. Co-primary outcomes are culture conversion and tolerability of treatment.
The primary analysis for culture conversion will be conducted as a per-protocol
non-inferiority analysis, and the primary analysis for tolerability will be conducted as an
intention-to-treat superiority analysis.

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

- Prior multi-drug therapy for pulmonary NTM

- Cystic fibrosis

- 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
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