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

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.

Conditions

• Mycobacterium Avium Complex
• Nontuberculous Mycobacterium Infection

Interventions

DRUG

Azithromycin

Azithromycin 500 MG Oral Tablet \[ZITHROMAX\]

DRUG

Ethambutol

Ethambutol 25 mg/kg \[MYAMBUTOL\]

DRUG

Rifampin

Rifampin 600 MG \[RIFADIN\]

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• National Jewish Health

  collaborator OTHER

• The University of Texas Health Science Center at Tyler

  collaborator OTHER

• University Health Network, Toronto

  collaborator OTHER

• New York University

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Louisiana State University Health Sciences Center in New Orleans

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Stanford University

  collaborator OTHER

• University of Kansas

  collaborator OTHER

• Vancouver Clinic

  collaborator UNKNOWN

• University of California, San Francisco

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of Miami

  collaborator OTHER

• Emory University

  collaborator OTHER

• University of Iowa

  collaborator OTHER

• University of North Carolina

  collaborator OTHER

• Temple University

  collaborator OTHER

• Loma Linda University

  collaborator OTHER

• Columbia University

  collaborator OTHER

• University of Wisconsin, Madison

  collaborator OTHER

• Northwell Health

  collaborator OTHER

• Kaiser Permanente

  collaborator OTHER

• James A. Haley Veterans Administration Hospital

  collaborator FED

• Kevin Winthrop

  lead OTHER

Principal Investigators

• Emily Henkle, PhD, MPH · Oregon Health and Science University

• Kevin L Winthrop, MD, MPH · Oregon Health and Science University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-22

Primary Completion

2026-01-08

Completion

2026-01-08

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations