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Macrolide Antibiotic

Antibiotic Therapy for Mycobacterium Avium Complex Infection (MAC2v3 Trial)

Phase 2 & 3

Recruiting

Led By Kevin L Winthrop, MD, MPH

Research Sponsored by Kevin Winthrop

Eligibility Criteria Checklist

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

Must have

Culture positive pulmonary MAC meeting ATS/IDSA disease criteria

Age over 18 years

Must not have

Fibrocavitary disease

Planned surgery for MAC disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether a three-drug regimen or a two-drug regimen is better for treating NTM infections. Common side effects include nausea, diarrhea, and fatigue, and rare but serious toxicities include ocular toxicity, hearing loss, and hematologic toxicity.

Who is the study for?

This trial is for adults over 18 who can consent and have a confirmed pulmonary Mycobacterium Avium Complex (MAC) infection. It's not for those with severe lung damage, planned lung surgery, extensive prior MAC treatment, cystic fibrosis, organ transplants, unmanageable drug interactions, or HIV.

What is being tested?

The study tests if two antibiotics (Azithromycin and Ethambutol) are as effective as three by adding Rifampin in treating pulmonary MAC disease. The goal is to see if fewer drugs reduce side effects without losing benefits during the usual 18-24 month treatment period.

What are the potential side effects?

Common side effects of these antibiotics include nausea, diarrhea, fatigue; rare but serious ones involve eye problems, hearing loss and blood issues. The trial aims to find out if reducing the number of medications lessens these risks.

Eligibility Criteria

Inclusion Criteria

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

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I have a confirmed lung infection caused by MAC bacteria.

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I am over 18 years old.

Exclusion Criteria

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

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I have fibrocavitary lung disease.

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I am scheduled for surgery to treat my MAC infection.

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I have been on antibiotics for MAC for 6 weeks or more.

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I have been diagnosed with Cystic Fibrosis.

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I have been diagnosed with HIV.

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I have had an organ or bone marrow transplant.

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I am allergic or cannot tolerate one of the medications in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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

Acid-fast bacilli (AFB) culture negativity

Therapy completion

Secondary study objectives

Fatigue AE proportion

Gastrointestinal AE proportion

Liver AE proportion

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: 2-drug regimenActive Control2 Interventions

This arm is a 3 time per week (TIW) treatment regimen that includes azithromycin 500 mg po + ethambutol 25 mg/kg Treatment changes are at the discretion of the treating physician and patient. Where possible, changes in dosing or frequency that allow the patient to continue taking the assigned drugs during the 12 months study period are preferred.

Group II: 3-drug regimenActive Control3 Interventions

This arm is a 3 time per week (TIW) treatment regimen that includes azithromycin 500 mg po + ethambutol 25 mg/kg + rifampin 600 mg Treatment changes are at the discretion of the treating physician and patient. Where possible, changes in dosing or frequency that allow the patient to continue taking the assigned drugs during the 12 months study period are preferred.

0 / 9Eligibility criteria met