A Study of Standard Drugs for Mycobacterium Avium Complex

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Mycobacterium Avium Complex

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04287049

IRB00221119

K23AI159145-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

To assess the early bactericidal activity of Azithromycin 250mg by mouth daily over the first 14 days of treatment for Mycobacterium avium complex (MAC) lung disease.

Full description

This research is being done to better understand several important aspects of treatment of Mycobacterium avium complex (MAC) lung infections using an early bactericidal activity (EBA) study design. MAC is an environmental bacteria that can cause chronic lung infection. Early bactericidal activity is the amount of bacterial killing that occurs during the first few weeks of antibiotic treatment. By collecting information about the EBA of azithromycin for MAC, the investigators will quantify the efficacy of azithromycin against pulmonary MAC.

Enrollment: 10 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Isolation of M. avium intracellulare complex from a respiratory specimen in the preceding 6 months
• Fulfill American Thoracic Society (ATS)/Infectious Diseases Society of America (IDSA) criteria for MAC lung disease
• Intention by the treating clinician to treat for MAC lung disease.
• Ability to produce a sputum sample of at least 10mL in a 16 hour period
• Signed informed consent by the subject

Exclusion criteria

• Prior treatment for pulmonary MAC within the past 6 months
• Pregnancy
• HIV with a cluster of differentiation 4 (CD4) <350
• History of solid organ or hematologic transplant
• Contraindication to azithromycin
• Has any other condition that, in the opinion of the PI, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

14 Day Azithromycin Monotherapy

Experimental group

Description:

For the first 14 days of therapy, participants will receive Azithromycin 250mg PO daily as monotherapy. Beyond day 14, all participants will receive guideline-based standard multi-drug therapy for Mycobacterium avium lung disease, as dictated by the physicians treating the participants.

Treatment:

Drug: Azithromycin