Antibiotic Therapy for Mycobacterium Avium Complex Infection (MAC2v3 Trial)

Palo Alto (17 mi)

Kevin Winthrop M.D., M.P.H. | Health ...

Overseen byKevin L Winthrop, MD, MPH

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Kevin Winthrop

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?NTM therapy consists of a multi-drug macrolide based regimen for 18-24 months. Treated patients frequently experience debilitating side effects, and many patients delay the start of antibiotic treatment due to these risks. Common side effects include nausea, diarrhea, and fatigue, and rare but serious toxicities include ocular toxicity, hearing loss, and hematologic toxicity. To date, most of the evidence underlying the current treatment recommendations has come from observational studies in which either a macrolide has been combined with rifampin and ethambutol, or in some cases combined with ethambutol alone. The proposed study will answer whether a third drug is necessary or whether taking two drugs can increase tolerability without a substantial loss of efficacy.

Eligibility Criteria

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.

Inclusion Criteria

I have a confirmed lung infection caused by MAC bacteria.

I am over 18 years old.

Exclusion Criteria

I have fibrocavitary lung disease.

I am scheduled for surgery to treat my MAC infection.

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

I have been diagnosed with Cystic Fibrosis.

I have been diagnosed with HIV.

I have had an organ or bone marrow transplant.

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

Treatment Details

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.

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.

Azithromycin is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Azithromycin for: