A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)

Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD) Clinical Trial

Official title: A Phase 2/3, Multicenter, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)

Status Recruiting

Clinical Trial Summary

The purpose of the study is to evaluate the efficacy of bedaquiline (BDQ) compared with rifamycin when administered as part of a treatment regimen with clarithromycin (CAM) and ethambutol (EB) in adult participants with treatment-refractory Mycobacterium avium complex-lung disease (MAC-LD) at Week 24 for microbiological assessment in mycobacteria growth indicator tube (MGIT).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Lung Diseases
• Mycobacterium avium-intracellulare Infection
• Mycobacterium Infections
• Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)

• NCT number: NCT04630145
• Study type: Interventional
• Source: Janssen Pharmaceutical K.K.
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study@its.jnj.com
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 8, 2021
• Completion date: February 10, 2026