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)
CompletedPhase 2, PHASE3Results postedLast updated 15 April 2026
What this trial tests
Phase 2, PHASE3 trial testing Bedaquiline in Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD) in 129 participants. Completed in 14 November 2025.
Adults 20 to 79, any sex, with Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24Primary· At Week 24
Number of participants with sputum culture conversion in MGIT at Week 24 was reported. Sputum culture conversion was defined as 3 consecutive negative sputum cultures taken at least 25 days apart.
Group
Value
95% CI
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
Number of Participants With Sputum Culture Conversion in 7H11 Agar Media at Week 24Secondary· At week 24
Number of participants with sputum culture conversion in 7H11 agar media at Week 24 was reported. Sputum culture conversion was defined as 3 consecutive negative sputum cultures taken at least 25 days apart based on actual collection dates.
Group
Value
95% CI
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
Change From Baseline in Patient Reported Health Status on Total Score of St. George's Respiratory Questionnaire (SGRQ) at Week 24Secondary· Baseline (Day 1), Week 24
SGRQ is a 50-item questionnaire with 76 weighted responses. It provides a total score and three component scores: Symptoms (distress caused by respiratory symptoms), Activity (physical activities that cause or are limited by breathlessness), and Impacts (social and psychological effects of the disease). The composite total score is derived from the 3 domain scores. Each domain score and the total score has a range of 0 to 100, with 0 indicating the best possible quality of life. An increase in score indicates worsening health.
Group
Value
95% CI
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
Change From Baseline in Lung Function Parameters at Week 24Secondary· Baseline (Day 1), Week 24
Change from baseline in lung function parameters (Forced expiratory volume in one second, Forced vital capacity, Inspiratory capacity, Functional residual capacity, Total lung capacity) at Week 24 was reported.
Forced expiratory volume in one second
Group
Value
95% CI
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
Percentage of Participants Who Underwent a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 24Secondary· Baseline (Day 1) up to Week 24
Percentage of participants who underwent a change in their Mycobacterium avium Complex-lung disease (MAC-LD) treatment regimen by Week 24 was reported.
Group
Value
95% CI
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
Time frame: All-cause mortality: From screening (Week -10) up to Week 24; Serious/other adverse events: From Baseline (Day 1) up to Week 24.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB)
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06192160 — Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
· Phase 2
· recruiting
NCT06081361 — Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis：Contezol
· Phase 3
· active not recruiting
NCT05766267 — Short-course Regimens for the Treatment of Pulmonary Tuberculosis
· Phase 2, PHASE3
· active not recruiting
NCT05824871 — A Phase III Study of Oral Sudapyridine (WX-081) Tablets in Rifampicin-Resistant Pulmonary Tuberculosis Patients
· Phase 3
· recruiting
NCT05382312 — Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established A
· Phase 2
· completed
Other Janssen Pharmaceutical K.K. trials
Trials by the same sponsor.
NCT06295692 — A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
· Phase 3
· active not recruiting
NCT05926583 — A Study of AAV5-hRKp.RPGR for the Treatment of Japanese Participants With X-linked Retinitis Pigmentosa
· Phase 3
· active not recruiting
NCT05567185 — A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
· Phase 1
· active not recruiting
NCT05167825 — A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension
· Phase 3
· completed
NCT05242432 — A Study of Adenovirus Serotype 26.Respiratory Syncytial Virus.Pre-Fusion F (Ad26.RSV.preF)-Based Vaccine for Prevention
· Phase 3
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Pharmaceutical K.K.
Last refreshed: 15 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04630145.