A Study of Standard Drugs for Mycobacterium Avium Complex

March 12, 2024 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins University School of Medicine
        • Contact:
        • Principal Investigator:
          • Elisa H Ignatius, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mycobacterium avium colony count in sputum
Time Frame: 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.
Baseline and Day 14
Change in time to positivity of Mycobacterium avium growth in the Mycobacterial Growth Indicator Tube (MGIT)
Time Frame: Baseline and Day 14
The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between Baseline and Day 14.
Baseline and Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mycobacterium avium colony count in sputum
Time Frame: 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.
Baseline and Day 7
Change in Mycobacterium avium colony count in sputum
Time Frame: 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.
Day 7 to Day 14
Change in Mycobacterium avium colony count in sputum
Time Frame: 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.
Baseline and 2 Months
Change in time to positivity of Mycobacterium avium growth in MGIT
Time Frame: Baseline and Day 7
The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between baseline and day 7.
Baseline and Day 7
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.
Day 7 and Day 14
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.
Baseline and 2 Months
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, 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.
Pre-dose, 2, 4 and 6 hours post-dose on day 15, and 2 and 6 hours post-dose on day 29
Estimation of maximum plasma concentration (Cmax) of azithromycin
Time Frame: 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.
Pre-dose, 2, 4 and 6 hours post-dose on day 15
Estimation of maximum plasma concentration (Cmax) of azithromycin
Time Frame: 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.
2 and 6 hours post-dose on day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Investigators

  • Principal Investigator: Elisa H Ignatius, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2020

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00221119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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