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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

MAC2v3 Trial 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.Check my eligibility

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.See study design

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.

MAC2v3 Trial 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.

MAC2v3 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acid-fast bacilli (AFB) culture negativity

Therapy completion

Secondary outcome measures

Fatigue AE proportion

Gastrointestinal AE proportion

Liver AE proportion

+4 more

MAC2v3 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kaiser Permanente HawaiiUNKNOWN

Johns Hopkins UniversityOTHER

2,260 Previous Clinical Trials

14,820,280 Total Patients Enrolled

University of IowaOTHER

446 Previous Clinical Trials

879,002 Total Patients Enrolled

Media Library

Azithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03672630 — Phase 2 & 3

Mycobacterium Avium Complex Infection Research Study Groups: 2-drug regimen, 3-drug regimen

Mycobacterium Avium Complex Infection Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT03672630 — Phase 2 & 3

Azithromycin (Macrolide Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03672630 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are we testing for in this clinical trial?

"The goal of this clinical trial is to monitor patients for Therapy completion over the course of 12 months. Secondary objectives include measuring the Quality of Life-Bronchiectasis (QOL-B) Respiratory Symptoms Score, the QOL-B NTM Symptoms Score, and the proportion of patients with Laboratory grade 2 or higher abnormalities."

Answered by AI

At how many hospitals or other research facilities is this trial being conducted?

"There are a total of 22 clinical trial sites where this research is being conducted. Some notable locations are Mayo Clinic in Rochester, Emory University in Atlanta, and Loma Linda University Medical Center in Loma Linda."

Answered by AI

Have there been other studies that looked at the effects of two different drugs?

"There are a total of 84 clinical trials underway that are studying 2-drug regimens. Of those, 27 are in Phase 3. Most of the research for 2-drug regimens is being conducted in Quilmes, Buenos Aires; however, there are 925 research sites around the world."

Answered by AI

What illness does the 2-drug regimen help cure most often?

"Genital ulcer disease (GUD) is most often treated with a two-drug medication plan. This approach can also be helpful in treating other conditions such as chlamydia, adult patients, and cervicitis."

Answered by AI

Are new participants still being enrolled in this experiment?

"Yes, as of 8/9/2022, this clinical trial is still recruiting patients. 22 sites across the U.S. are looking to enroll a total of 500 individuals."

Answered by AI

Who else is applying?

What state do they live in?

California

What site did they apply to?

University of California, San Diego

Mayo Clinic

University of North Carolina

Other

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

IM a TRIAL RESEACHERS DREAM. Gonna need some second opinion diagnoses. I want to resolve my situation. I have three or four episodes each year and have not been treated because of some cardiac issues.

PatientReceived no prior treatments

Recent research and studies

Annals of the American Thoracic SocietyJournal

Lack of Adherence to Evidence-based Treatment Guidelines for Nontuberculous Mycobacterial Lung Disease

Adjemian, Jennifer, D. Rebecca Prevots, Jack Gallagher, Kylee Heap, Renu Gupta, and David Griffith. 2014. “Lack of Adherence to Evidence-based Treatment Guidelines for Nontuberculous Mycobacterial Lung Disease”. Annals of the American Thoracic Society. American Thoracic Society. doi:10.1513/annalsats.201304-085oc.

American Journal of Respiratory and Critical Care MedicineJournal

Pulmonary Nontuberculous Mycobacterial Disease Prevalence and Clinical Features

Winthrop, Kevin L., Erin McNelley, Brian Kendall, Allison Marshall-Olson, Christy Morris, Maureen Cassidy, Ashlen Saulson, and Katrina Hedberg. 2010. “Pulmonary Nontuberculous Mycobacterial Disease Prevalence and Clinical Features”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/rccm.201003-0503oc.

mycobacterium AbscessusJournal

Once-daily Dosing of Amikacin for Treatment of <i>mycobacterium Abscessus</i> Lung Disease

Lee, H., Y. M. Sohn, J. Y. Ko, S-Y. Lee, B. W. Jhun, H. Y. Park, K. Jeon, et al.. 2017. “Once-daily Dosing of Amikacin for Treatment of mycobacterium Abscessus Lung Disease”. The International Journal of Tuberculosis and Lung Disease. International Union Against Tuberculosis and Lung Disease. doi:10.5588/ijtld.16.0791.

ChestJournal