A Study of Standard Drugs for Mycobacterium Avium Complex

Johns Hopkins University10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mycobacterium Avium Complex

Interventions

AzithromycinDRUG

Azithromycin 250 mg PO daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Change in Mycobacterium avium colony count in sputum

The early bactericidal activity of azithromycin for Mycobacterium avium will be determined as the change in Mycobacterium avium colony count (log10 colony forming unit (CFU) per mL) in sputum between baseline and day 14.

Time frame: Baseline and Day 14

Change in time to positivity of Mycobacterium avium growth in the Mycobacterial Growth Indicator Tube (MGIT)

The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between Baseline and Day 14.

Time frame: Baseline and Day 14

Secondary Outcomes

Change in Mycobacterium avium colony count in sputum

The bactericidal activity of multidrug therapy for Mycobacterium avium will be determined as the change in Mycobacterium avium colony count (log10 CFU per mL) in sputum between baseline and day 7.

Time frame: Baseline and Day 7

Change in Mycobacterium avium colony count in sputum

The bactericidal activity of multidrug therapy for Mycobacterium avium will be determined as the change in Mycobacterium avium colony count (log10 CFU per mL) in sputum between day 7 and day 14.

Time frame: Day 7 to Day 14

Change in Mycobacterium avium colony count in sputum

The bactericidal activity of multidrug therapy for Mycobacterium avium will be determined as the change in Mycobacterium avium colony count (log10 CFU per mL) in sputum between baseline and 2 months.

Time frame: Baseline and 2 Months

Change in time to positivity of Mycobacterium avium growth in MGIT

The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between baseline and day 7.

Data from ClinicalTrials.gov

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