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Macrolide Antibiotic

Azithromycin for MAC Infection

Phase 2

Recruiting

Led By Keira A Cohen, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Ability to produce a sputum sample of at least 10mL in a 16 hour period

Must not have

History of solid organ or hematologic transplant

HIV with a cluster of differentiation 4 (CD4) <350

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 2 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the effectiveness of the antibiotic azithromycin in treating MAC lung disease.

Who is the study for?

This trial is for adults over 18 with MAC lung disease, as defined by ATS/IDSA criteria. Participants must have had a positive test for M. avium complex in the last 6 months and be able to produce a sputum sample. They cannot join if they've had an organ transplant, are allergic to azithromycin, were treated for MAC recently, are pregnant or have HIV with CD4 <350.

What is being tested?

The study tests Azithromycin's effectiveness against Mycobacterium avium complex (MAC) infection over the first two weeks of treatment. Patients will take 250mg of Azithromycin orally every day.

What are the potential side effects?

Azithromycin may cause side effects like stomach upset, diarrhea, nausea, vomiting and can sometimes lead to more serious conditions such as liver problems or heart rhythm changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can produce a large enough sputum sample within 16 hours.

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I meet the criteria for MAC lung disease as per ATS/IDSA.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had an organ or bone marrow transplant.

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My CD4 count is below 350.

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I have been treated for lung MAC within the last 6 months.

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I cannot take azithromycin due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in time to positivity of Mycobacterium avium growth in the Mycobacterial Growth Indicator Tube (MGIT)

Secondary study objectives

Change in Mycobacterium avium colony count in sputum

Change in time to positivity of Mycobacterium avium growth in MGIT

Estimation of maximum plasma concentration (Cmax) of azithromycin

+1 more

Side effects data

From 2022 Phase 4 trial • 42 Patients • NCT05027516

pain at injection site

100%

80%

60%

40%

20%

Study treatment Arm

Rocephine®

Rocephine® + Azithromycin

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 14 Day Azithromycin MonotherapyExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azithromycin

2018

Completed Phase 4

~274950

0 / 7Eligibility criteria met