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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    500
  • sponsor
    Kevin Winthrop
Updated on 27 January 2021
antibiotic therapy
antibiotics
nausea
diarrhea
azithromycin
rifampin
macrolides
ethambutol

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.

Description

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.

Details
Condition Mycobacterium avium-intracellulare Infection, Mycobacterium avium Complex, MAC Infection (Mycobacterium Avium Complex), Nontuberculous Mycobacterium Infection
Treatment ethambutol, Azithromycin, rifampin
Clinical Study IdentifierNCT03672630
SponsorKevin Winthrop
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Nontuberculous Mycobacterium Infection or Mycobacterium avium-intracellulare Infection or Mycobacterium avium Complex or MAC Infection (Mycobacterium ...?
Do you have any of these conditions: Mycobacterium avium-intracellulare Infection or Mycobacterium avium Complex or Nontuberculous Mycobacterium Infection or MAC Infection (Mycobacterium ...?
Do you have any of these conditions: Mycobacterium avium Complex or Mycobacterium avium-intracellulare Infection or MAC Infection (Mycobacterium Avium Complex) or Nontuberculous Mycobacte...?
Do you have any of these conditions: Nontuberculous Mycobacterium Infection or Mycobacterium avium-intracellulare Infection or Mycobacterium avium Complex or MAC Infection (Mycobacterium ...?
Do you have any of these conditions: Mycobacterium avium-intracellulare Infection or MAC Infection (Mycobacterium Avium Complex) or Nontuberculous Mycobacterium Infection or Mycobacterium...?
Do you have any of these conditions: Mycobacterium avium Complex or Mycobacterium avium-intracellulare Infection or Nontuberculous Mycobacterium Infection or MAC Infection (Mycobacterium ...?
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
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