A Study of Standard Drugs for Mycobacterium Avium Complex
- Registration Number
- NCT04287049
- Lead Sponsor
- Johns Hopkins University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 14 Day Azithromycin Monotherapy Azithromycin 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.
- Primary Outcome Measures
Name Time Method Change in Mycobacterium avium colony count in sputum Baseline and Day 14 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.
Change in time to positivity of Mycobacterium avium growth in the Mycobacterial Growth Indicator Tube (MGIT) Baseline and Day 14 The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between Baseline and Day 14.
- Secondary Outcome Measures
Name Time Method Change in Mycobacterium avium colony count in sputum Baseline and 2 Months 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.
Change in time to positivity of Mycobacterium avium growth in MGIT Baseline and 2 Months The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between baseline and 2 months.
Estimation of plasma azithromycin area-under-the-curve (AUC) following oral dosing azithromycin Pre-dose, 2, 4 and 6 hours post-dose on day 15, and 2 and 6 hours post-dose on day 29 Area-under-the-curve (ug/mL\*hr) will be predicted from plasma azithromycin levels using population pharmacokinetic modeling methods.
Estimation of maximum plasma concentration (Cmax) of azithromycin 2 and 6 hours post-dose on day 29 Peak concentration (Cmax) will be predicted from plasma drug concentration in ug/mL following oral dosing of azithromycin.
Trial Locations
- Locations (1)
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States