At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Bedaquiline, Clarithromycin, and 3 other interventions for Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD). Completed, enrolled 129 participants across 55 sites in 3 countries.
Detailed 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).
Study Details
Timeline
Interventions
Participants will receive BDQ tablets only/
Participants will receive CAM 400 or 500 mg twice a day.
Participants will receive 500 to 750 mg daily (maximum daily dose of 1.0 gram \[g\]) or 15 mg/kg once a day.
Participants will receive daily dose is 450 mg (maximum 600 mg) RFP capsule once a day.
Participants will receive daily dose of RBT 300 mg or 150 mg capsules once a day.