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A Study of Standard Drugs for Mycobacterium Avium Complex

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04287049
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
50.5
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Early Bactericidal Activity of Standard Drugs Used to Treat Mycobacterium Avium Complex: a Pilot Study
Actual Study Start Date :
Feb 24, 2020
Anticipated Primary Completion Date :
Mar 10, 2024
Anticipated Study Completion Date :
May 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 14 Day Azithromycin Monotherapy

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.

Drug: Azithromycin
Azithromycin 250 mg PO daily
Other Names:
  • Zithromax

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    1. Change in Mycobacterium avium colony count in sputum [Baseline and Day 7]

      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.

    2. Change in Mycobacterium avium colony count in sputum [Day 7 to Day 14]

      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.

    3. 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.

    4. Change in time to positivity of Mycobacterium avium growth in MGIT [Baseline and Day 7]

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

    5. Change in time to positivity of Mycobacterium avium growth in MGIT [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. 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.

    7. 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.

    8. Estimation of maximum plasma concentration (Cmax) of azithromycin [Pre-dose, 2, 4 and 6 hours post-dose on day 15]

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

    9. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins University School of Medicine Baltimore Maryland United States 21205

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

    • Principal Investigator: Kelly Dooley, Johns Hopkins University
    • Study Director: Elisa H Ignatius, MD, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT04287049
    Other Study ID Numbers:
    • IRB00221119
    First Posted:
    Feb 27, 2020
    Last Update Posted:
    Mar 9, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mycobacterium Infections
    Mycobacterium avium-intracellulare Infection
    Azithromycin

    Study Results

    No Results Posted as of Mar 9, 2022