Mycobacterium Avium ComplexPhase 2NCT04287049

A Study of Standard Drugs for Mycobacterium Avium Complex

A Phase 2 study testing Azithromycin in people with Mycobacterium Avium Complex, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Mycobacterium Avium Complex
What is being tested?: Azithromycin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 24 Feb 2020to 21 Mar 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Mycobacterium Avium Complex
Being tested: Azithromycin
Medical subject headings: Mycobacterium avium-intracellulare Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AzithromycinDrug
Also called Zithromax
Azithromycin 250 mg PO daily

Study groups in NCT04287049
Study group	Role	What they receive
14 Day Azithromycin Monotherapy	Experimental	For the first 14 days of therapy, participants will receive Azithromycin 250mg by mouth (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. Receives: Drug: Azithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change in Mycobacterium Avium Colony Count in Sputum
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.
Measured: Day 0 and Day 15
Mean Change in Time to Positivity of Mycobacterium Avium Growth in the Mycobacterial Growth Indicator Tube (MGIT)
The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between baseline and day 15.
Measured: Day 0 and Day 15

Secondary outcomes (10)

Mean Change in Mycobacterium Avium Colony Count in Sputum
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.
Measured: Day 0 and Day 8
Mean Change in Mycobacterium Avium Colony Count in Sputum
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.
Measured: Day 8 to Day 15
Mean Change in Mycobacterium Avium Colony Count in Sputum
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.
Measured: Day 0 and 2 Months
Mean Change in Time to Positivity of Mycobacterium Avium Growth in MGIT
The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between baseline and day 8.
Measured: Day 0 and Day 8
Mean Change in Time to Positivity of Mycobacterium Avium Growth in MGIT
The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between day 7 and day 14.
Measured: Day 7 and Day 14
Mean Change in Time to Positivity of Mycobacterium Avium Growth in MGIT
The time (hours) to positivity in MGIT of Mycobacterium avium will be compared between baseline and 2 months.
Measured: Baseline and 2 Months
Estimation of Plasma Azithromycin Area-under-the-curve (AUC) Following Oral Dosing Azithromycin
Area-under-the-curve (ug/mL*hr) will be predicted from plasma azithromycin levels using population pharmacokinetic modeling methods.
Measured: Pre-dose, 2, 4 and 6 hours post-dose on day 15 (range: 11-19 days)
Estimation of Plasma Azithromycin Area-under-the-curve (AUC) Following Oral Dosing Azithromycin
Area-under-the-curve (ug/mL*hr) will be predicted from plasma azithromycin levels using population pharmacokinetic modeling methods.
Measured: 2 and 6 hours post-dose on day 29 (range: 25-31 days)
Estimation of Maximum Plasma Concentration (Cmax) of Azithromycin
Peak concentration (Cmax) will be predicted from plasma drug concentration in ug/mL following oral dosing of azithromycin.
Measured: Pre-dose, 2, 4 and 6 hours post-dose on day 15 (range: 11-19 days)
Estimation of Maximum Plasma Concentration (Cmax) of Azithromycin
Peak concentration (Cmax) will be predicted from plasma drug concentration in ug/mL following oral dosing of azithromycin.
Measured: 2 and 6 hours post-dose on day 29 (range: 25-31 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Feb 202021 Mar 2025

First posted27 Feb 2020
Study start24 Feb 2020
Primary completion21 Mar 2025
Study completion21 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Mycobacterium Avium ComplexStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04287049
Sponsor's protocol ID: IRB00221119
Other IDs: K23AI159145-01A1
Status last verified: May 2026
First submitted: 25 Feb 2020
Last updated: 15 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, Holland SM, Horsburgh R, Huitt G, Iademarco MF, Iseman M, Olivier K, Ruoss S, von Reyn CF, Wallace RJ Jr, Winthrop K; ATS Mycobacterial Diseases Subcommittee; American Thoracic Society; Infectious Disease Society of America. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007 Feb 15;175(4):367-416. doi: 10.1164/rccm.200604-571ST. No abstract available.
PubMed 17277290
Ryu YJ, Koh WJ, Daley CL. Diagnosis and Treatment of Nontuberculous Mycobacterial Lung Disease: Clinicians' Perspectives. Tuberc Respir Dis (Seoul). 2016 Apr;79(2):74-84. doi: 10.4046/trd.2016.79.2.74. Epub 2016 Mar 31.
PubMed 27066084
Griffith DE, Brown BA, Cegielski P, Murphy DT, Wallace RJ Jr. Early results (at 6 months) with intermittent clarithromycin-including regimens for lung disease due to Mycobacterium avium complex. Clin Infect Dis. 2000 Feb;30(2):288-92. doi: 10.1086/313644.
PubMed 10671330
Koh WJ, Moon SM, Kim SY, Woo MA, Kim S, Jhun BW, Park HY, Jeon K, Huh HJ, Ki CS, Lee NY, Chung MJ, Lee KS, Shin SJ, Daley CL, Kim H, Kwon OJ. Outcomes of Mycobacterium avium complex lung disease based on clinical phenotype. Eur Respir J. 2017 Sep 27;50(3):1602503. doi: 10.1183/13993003.02503-2016. Print 2017 Sep.
PubMed 28954780
Asakura T, Nakagawa T, Suzuki S, Namkoong H, Morimoto K, Ishii M, Kurashima A, Betsuyaku T, Ogawa K, Hasegawa N; Nontuberculous Mycobacteriosis Japan Research Consortium (NTM-JRC). Efficacy and safety of intermittent maintenance therapy after successful treatment of Mycobacterium avium complex lung disease. J Infect Chemother. 2019 Mar;25(3):218-221. doi: 10.1016/j.jiac.2018.07.021. Epub 2018 Aug 29.
PubMed 30172726
Jindani A, Aber VR, Edwards EA, Mitchison DA. The early bactericidal activity of drugs in patients with pulmonary tuberculosis. Am Rev Respir Dis. 1980 Jun;121(6):939-49. doi: 10.1164/arrd.1980.121.6.939. No abstract available.
PubMed 6774638
Diacon AH, Dawson R, von Groote-Bidlingmaier F, Symons G, Venter A, Donald PR, van Niekerk C, Everitt D, Winter H, Becker P, Mendel CM, Spigelman MK. 14-day bactericidal activity of PA-824, bedaquiline, pyrazinamide, and moxifloxacin combinations: a randomised trial. Lancet. 2012 Sep 15;380(9846):986-93. doi: 10.1016/S0140-6736(12)61080-0. Epub 2012 Jul 23.
PubMed 22828481
Donald PR, Diacon AH. The early bactericidal activity of anti-tuberculosis drugs: a literature review. Tuberculosis (Edinb). 2008 Aug;88 Suppl 1:S75-83. doi: 10.1016/S1472-9792(08)70038-6.
PubMed 18762155
Slaats MH, Hoefsloot W, Magis-Escurra C, Boeree MJ, Wattenberg M, Kuipers S, van Ingen J. Regimens for nontuberculous mycobacterial lung disease lack early bactericidal activity. Eur Respir J. 2016 Mar;47(3):1000-2. doi: 10.1183/13993003.00925-2015. Epub 2015 Dec 2. No abstract available.
PubMed 26647433
Wallace RJ Jr, Brown BA, Griffith DE, Girard WM, Murphy DT, Onyi GO, Steingrube VA, Mazurek GH. Initial clarithromycin monotherapy for Mycobacterium avium-intracellulare complex lung disease. Am J Respir Crit Care Med. 1994 May;149(5):1335-41. doi: 10.1164/ajrccm.149.5.8173775.
PubMed 8173775

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Study of Mycobacterial Infections
Mycobacterium Infections
RecruitingPhase 4
Prevention of Recurrence With Cordyceps Sinensis in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingPhase 4
Short-term Bactericidal Effect of Contezolid in MAC-PD
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Pathogenesis and Genetics of Microphthalmia, Anophthalmia and Uveal Coloboma (MAC)
Coloboma, Anophthalmia

All Mycobacterium Avium Complex trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Bactericidal Activity of Standard Drugs Used to Treat Mycobacterium Avium Complex: a Pilot Study
ClinicalTrials.gov ID: NCT04287049
Acronym / sponsor ID: IRB00221119
Conditions: Mycobacterium Avium Complex
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), American College of Chest Physicians
Study start: 24 Feb 2020 (actual)
Primary completion: 21 Mar 2025 (actual)
Study completion: 21 Mar 2025 (actual)
First posted: 27 Feb 2020 (actual)
Results: Posted 22 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
14 Day Azithromycin Monotherapy	Experimental	Drug: AzithromycinFor the first 14 days of therapy, participants will receive Azithromycin 250mg by mouth (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.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AzithromycinAlso: ZithromaxAzithromycin 250 mg PO daily	Drug	14 Day Azithromycin Monotherapy

Primary outcome

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.
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.

10 secondary outcomes

Mean Change in Mycobacterium Avium Colony Count in Sputum
Time frame: Day 0 and Day 8
Mean Change in Mycobacterium Avium Colony Count in Sputum
Time frame: Day 8 to Day 15
Mean Change in Mycobacterium Avium Colony Count in Sputum
Time frame: Day 0 and 2 Months
Mean Change in Time to Positivity of Mycobacterium Avium Growth in MGIT
Time frame: Day 0 and Day 8
Mean Change in Time to Positivity of Mycobacterium Avium Growth in MGIT
Time frame: Day 7 and Day 14
Mean Change in Time to Positivity of Mycobacterium Avium Growth in MGIT
Time frame: 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 (range: 11-19 days)
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)
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)
Estimation of Maximum Plasma Concentration (Cmax) of Azithromycin
Time frame: 2 and 6 hours post-dose on day 29 (range: 25-31 days)

Results and safety

Results posted to the registry on 22 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
14 Day Azithromycin Monotherapy	10	9

Primary outcome: Mean Change in Mycobacterium Avium Colony Count in Sputum

Time frame: Day 0 and Day 15. Mean (Standard Deviation). Unit: log10 CFU/mL

Measure	14 Day Azithromycin Monotherapy n = 10
Value	-0.425 (1.39)

Primary outcome: Mean Change in Time to Positivity of Mycobacterium Avium Growth in the Mycobacterial Growth Indicator Tube (MGIT)

Time frame: Day 0 and Day 15. Mean (Standard Deviation). Unit: hours

Measure	14 Day Azithromycin Monotherapy n = 10
Value	101 (283)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Over the study period, at each visit, or if it is reported to the study team through hospitalization, for a total maximum duration up to 77 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
14 Day Azithromycin Monotherapy	0 of 10 (0%)	1 of 10 (10%)	1 of 10

Limitations and caveats (from the sponsor): The total sample size of N=10, while adequate for quantifying the early bactericidal activity (EBA), lacks the statistical power to perform subgroup analyses. Similarly, culture-based methods are inherently limited by their reliance on human capacity for sputum expectoration.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17277290Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, Holland SM, Horsburgh R, Huitt G, Iademarco MF, Iseman M, Olivier K, Ruoss S, von Reyn CF, Wallace RJ Jr, Winthrop K; ATS Mycobacterial Diseases Subcommittee; American Thoracic Society; Infectious Disease Society of America. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007 Feb 15;175(4):367-416. doi: 10.1164/rccm.200604-571ST. No abstract available.
Background: PubMed 27066084Ryu YJ, Koh WJ, Daley CL. Diagnosis and Treatment of Nontuberculous Mycobacterial Lung Disease: Clinicians' Perspectives. Tuberc Respir Dis (Seoul). 2016 Apr;79(2):74-84. doi: 10.4046/trd.2016.79.2.74. Epub 2016 Mar 31.
Background: PubMed 10671330Griffith DE, Brown BA, Cegielski P, Murphy DT, Wallace RJ Jr. Early results (at 6 months) with intermittent clarithromycin-including regimens for lung disease due to Mycobacterium avium complex. Clin Infect Dis. 2000 Feb;30(2):288-92. doi: 10.1086/313644.
Background: PubMed 28954780Koh WJ, Moon SM, Kim SY, Woo MA, Kim S, Jhun BW, Park HY, Jeon K, Huh HJ, Ki CS, Lee NY, Chung MJ, Lee KS, Shin SJ, Daley CL, Kim H, Kwon OJ. Outcomes of Mycobacterium avium complex lung disease based on clinical phenotype. Eur Respir J. 2017 Sep 27;50(3):1602503. doi: 10.1183/13993003.02503-2016. Print 2017 Sep.
Background: PubMed 30172726Asakura T, Nakagawa T, Suzuki S, Namkoong H, Morimoto K, Ishii M, Kurashima A, Betsuyaku T, Ogawa K, Hasegawa N; Nontuberculous Mycobacteriosis Japan Research Consortium (NTM-JRC). Efficacy and safety of intermittent maintenance therapy after successful treatment of Mycobacterium avium complex lung disease. J Infect Chemother. 2019 Mar;25(3):218-221. doi: 10.1016/j.jiac.2018.07.021. Epub 2018 Aug 29.
Background: PubMed 6774638Jindani A, Aber VR, Edwards EA, Mitchison DA. The early bactericidal activity of drugs in patients with pulmonary tuberculosis. Am Rev Respir Dis. 1980 Jun;121(6):939-49. doi: 10.1164/arrd.1980.121.6.939. No abstract available.
Background: PubMed 22828481Diacon AH, Dawson R, von Groote-Bidlingmaier F, Symons G, Venter A, Donald PR, van Niekerk C, Everitt D, Winter H, Becker P, Mendel CM, Spigelman MK. 14-day bactericidal activity of PA-824, bedaquiline, pyrazinamide, and moxifloxacin combinations: a randomised trial. Lancet. 2012 Sep 15;380(9846):986-93. doi: 10.1016/S0140-6736(12)61080-0. Epub 2012 Jul 23.
Background: PubMed 18762155Donald PR, Diacon AH. The early bactericidal activity of anti-tuberculosis drugs: a literature review. Tuberculosis (Edinb). 2008 Aug;88 Suppl 1:S75-83. doi: 10.1016/S1472-9792(08)70038-6.
Background: PubMed 26647433Slaats MH, Hoefsloot W, Magis-Escurra C, Boeree MJ, Wattenberg M, Kuipers S, van Ingen J. Regimens for nontuberculous mycobacterial lung disease lack early bactericidal activity. Eur Respir J. 2016 Mar;47(3):1000-2. doi: 10.1183/13993003.00925-2015. Epub 2015 Dec 2. No abstract available.
Background: PubMed 8173775Wallace RJ Jr, Brown BA, Griffith DE, Girard WM, Murphy DT, Onyi GO, Steingrube VA, Mazurek GH. Initial clarithromycin monotherapy for Mycobacterium avium-intracellulare complex lung disease. Am J Respir Crit Care Med. 1994 May;149(5):1335-41. doi: 10.1164/ajrccm.149.5.8173775.
Individual participant dataSharing planned: No

Related trials for Mycobacterium Avium Complex

RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Study of Mycobacterial Infections
Mycobacterium Infections
RecruitingPhase 4
Prevention of Recurrence With Cordyceps Sinensis in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingPhase 4
Short-term Bactericidal Effect of Contezolid in MAC-PD
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Pathogenesis and Genetics of Microphthalmia, Anophthalmia and Uveal Coloboma (MAC)
Coloboma, Anophthalmia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elisa H Ignatius, MD principal investigator

Johns Hopkins University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Azithromycin in people with Mycobacterium Avium Complex, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Mycobacterium Avium Colony Count in Sputum (time frame: Day 0 and Day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04287049, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.