Clinical trial NCT04287049: A Study of Standard Drugs for Mycobacterium Avium Complex
Official title: Early Bactericidal Activity of Standard Drugs Used to Treat Mycobacterium Avium Complex: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mycobacterium Avium Complex
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: American College of Chest Physicians
First posted: 2020-02-27
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Mycobacterium avium colony count in sputum
timeFrame: Baseline and Day 14
measure: Change in time to positivity of Mycobacterium avium growth in the Mycobacterial Growth Indicator Tube (MGIT)
timeFrame: Baseline and Day 14
Secondary outcomes:
measure: Change in Mycobacterium avium colony count in sputum
timeFrame: Baseline and Day 7
measure: Change in Mycobacterium avium colony count in sputum
timeFrame: Day 7 to Day 14
measure: Change in Mycobacterium avium colony count in sputum
timeFrame: Baseline and 2 Months
measure: Change in time to positivity of Mycobacterium avium growth in MGIT
timeFrame: Baseline and Day 7
measure: Change in time to positivity of Mycobacterium avium growth in MGIT
timeFrame: Day 7 and Day 14
measure: Change in time to positivity of Mycobacterium avium growth in MGIT
timeFrame: Baseline and 2 Months
measure: Estimation of plasma azithromycin area-under-the-curve (AUC) following oral dosing azithromycin
timeFrame: Pre-dose, 2, 4 and 6 hours post-dose on day 15, and 2 and 6 hours post-dose on day 29
measure: Estimation of maximum plasma concentration (Cmax) of azithromycin
timeFrame: Pre-dose, 2, 4 and 6 hours post-dose on day 15
measure: Estimation of maximum plasma concentration (Cmax) of azithromycin
timeFrame: 2 and 6 hours post-dose on day 29
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Elisa H Ignatius, MD
role: PRINCIPAL_INVESTIGATOR
References:
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