Mycobacterium Avium Complex Clinical Trial
Official title:
Phase 2 Study of Clofazimine for the Treatment of Pulmonary Mycobacterium Avium Disease
The purpose of this study is to evaluate the clinical effectiveness and safety of clofazimine when used to treat Mycobacteria avium complex (MAC) lung disease. Funding Source - FDA OOPD
Clofazimine is an orphan antibiotic drug that is no longer available through pharmacies in the United States. It is approved for the treatment of Mycobacterium leprae (leprosy) infections. Clofazimine has been used for many years off-label against other Mycobacterium, including Mycobacteria avium complex (MAC) lung disease, an increasingly prevalent infection in older Americans. The U.S. Food and Drug Administration currently oversees clofazimine use to treat MAC lung disease through a special investigational drug access program. However, to date, there is little understanding of the benefits and risks of clofazimine when used to treat MAC lung disease. Accordingly, the investigators have developed a randomized, placebo-controlled clinical trial to assess the clinical efficacy and safety of clofazimine. To be eligible, participants must have MAC lung disease, positive sputum cultures for MAC, and not currently taking antibiotics for MAC. Eligible participants (102 total enrolled) will be randomly given either clofazimine or placebo for 6 months, and followed closely by their treating physician. The percentage of participants who become culture negative in each group will be compared, as it is suspected that participants treated with clofazimine will be more likely to become culture negative. The safety of clofazimine will be measured as well as other potential benefits of the therapy including changes in lung function and quality of life. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05192057 -
Hypertonic Saline Inhalation for Mycobacterium Avium Complex Pulmonary Disease
|
Phase 4 | |
| Withdrawn |
NCT01719042 -
Improving Tolerance of Treatment of Pulmonary MAC Infections
|
Phase 2 | |
| Completed |
NCT00600769 -
Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
|
Phase 4 | |
| Recruiting |
NCT03236987 -
CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections
|
Phase 3 | |
| Recruiting |
NCT04287049 -
A Study of Standard Drugs for Mycobacterium Avium Complex
|
Phase 2 | |
| Recruiting |
NCT03672630 -
Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease
|
Phase 2/Phase 3 | |
| Completed |
NCT04685720 -
A Pilot Study to Assess the Effect of Intermittent iNO on the Treatment of NTM Lung Infection in CF and Non-CF Patients
|
N/A | |
| Terminated |
NCT04553406 -
Safety, Tolerability, Pharmacokinetics and Efficacy of SPR720 for the Treatment of Patients With Mycobacterium Avium Complex (MAC) Pulmonary Disease
|
Phase 2 | |
| Completed |
NCT00598962 -
Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease
|
Phase 4 | |
| Recruiting |
NCT05824988 -
Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease
|