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Completed

NCT Number: NCT04287049

A Study of Standard Drugs for Mycobacterium Avium Complex

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.

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Key information

Conditions

Mycobacterium Avium Complex Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Mycobacterium Infections, Nontuberculous Mycobacterium avium-intracellulare Infection

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azithromycin

Drug

Azithromycin 250 mg PO daily

Other names: Zithromax

Primary outcomes

  1. Mean Change in Mycobacterium Avium Colony Count in Sputum

    Time frame: Day 0 and Day 15

    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 15.

  2. Mean Change in Time to Positivity of Mycobacterium Avium Growth in the Mycobacterial Growth Indicator Tube (MGIT)

    Time frame: Day 0 and Day 15

    The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between baseline and day 15.

Secondary outcomes

  1. Mean Change in Mycobacterium Avium Colony Count in Sputum

    Time frame: Day 0 and Day 8

    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 8.

  2. Mean Change in Mycobacterium Avium Colony Count in Sputum

    Time frame: Day 8 to Day 15

    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 8 and day 15.

  3. Mean Change in Mycobacterium Avium Colony Count in Sputum

    Time frame: Day 0 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.

  4. Mean Change in Time to Positivity of Mycobacterium Avium Growth in MGIT

    Time frame: Day 0 and Day 8

    The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between baseline and day 8.

  5. Mean Change in Time to Positivity of Mycobacterium Avium Growth in MGIT

    Time frame: Day 7 and Day 14

    The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between day 7 and day 14.

  6. Mean Change in Time to Positivity of Mycobacterium Avium Growth in MGIT

    Time frame: Baseline and 2 Months

    The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between baseline and 2 months.

  7. Estimation of Plasma Azithromycin Area-under-the-curve (AUC) Following Oral Dosing Azithromycin

    Time frame: Pre-dose, 2, 4 and 6 hours post-dose on day 15 (range: 11-19 days)

    Area-under-the-curve (ug/mL*hr) will be predicted from plasma azithromycin levels using population pharmacokinetic modeling methods.

  8. Estimation of Plasma Azithromycin Area-under-the-curve (AUC) Following Oral Dosing Azithromycin

    Time frame: 2 and 6 hours post-dose on day 29 (range: 25-31 days)

    Area-under-the-curve (ug/mL*hr) will be predicted from plasma azithromycin levels using population pharmacokinetic modeling methods.

  9. Estimation of Maximum Plasma Concentration (Cmax) of Azithromycin

    Time frame: Pre-dose, 2, 4 and 6 hours post-dose on day 15 (range: 11-19 days)

    Peak concentration (Cmax) will be predicted from plasma drug concentration in ug/mL following oral dosing of azithromycin.

  10. Estimation of Maximum Plasma Concentration (Cmax) of Azithromycin

    Time frame: 2 and 6 hours post-dose on day 29 (range: 25-31 days)

    Peak concentration (Cmax) will be predicted from plasma drug concentration in ug/mL following oral dosing of azithromycin.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • American College of Chest Physicians
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Early Bactericidal Activity of Standard Drugs Used to Treat Mycobacterium Avium Complex: a Pilot Study

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2020
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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