Phase 3
Completed N=129
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)
Source: ClinicalTrials.gov NCT04630145 ↗
Enrolled (actual)
129
Serious AEs
4.7%
Results posted
Apr 2026
Primary outcomePrimary: Number of Participants With Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24 — 3; 16 Participants — p==0.002
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sputum Culture Conversion in Mycobacteria Growth Indicator Tube (MGIT) at Week 24 |
3; 16 | =0.002 sig |
| SECONDARY Number of Participants With Sputum Culture Conversion in 7H11 Agar Media at Week 24 |
3; 16 | — |
| SECONDARY Change From Baseline in Patient Reported Health Status on Total Score of St. George's Respiratory Questionnaire (SGRQ) at Week 24 |
-0.2; -3.8 | — |
| SECONDARY Percentage of Participants With Sputum Culture Conversion in MGIT at Week 48 |
— | — |
| SECONDARY Percentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 48 |
— | — |
| SECONDARY Percentage of Participants With Sputum Culture Negativity in MGIT |
— | — |
| SECONDARY Percentage of Participants With Sputum Culture Negativity in 7H10 or 7H11 Agar Media |
— | — |
| SECONDARY Time to Sputum Culture Conversion in MGIT up to Week 48 |
— | — |
| SECONDARY Time to Positivity in MGIT up to Week 48 |
— | — |
| SECONDARY Change From Baseline in Patient-Reported Health Status on Total Score of SGRQ at Weeks 48 and 60 |
— | — |
| SECONDARY Change From Baseline in Lung Function Parameters at Week 24 |
-6.9; -14.3; 0.7; -16.0; -7.8; -37.7 | — |
| SECONDARY Change From Baseline in Lung Function Parameters at Weeks 48 and 60 |
— | — |
| SECONDARY Percentage of Participants Who Underwent a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 24 |
1.6; 1.5 | — |
| SECONDARY Percentage of Participants Who Underwent a Change in Their Mycobacterium Avium Complex-lung Disease (MAC-LD) Treatment Regimen by Week 48 and Week 60 |
— | — |
| SECONDARY Percentage of Participants With Sputum Culture Conversion in MGIT at Week 60 |
— | — |
| SECONDARY Percentage of Participants With Sputum Culture Conversion in 7H10 or 7H11 Agar Media at Week 60 |
— | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
— | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Laboratory Tests |
— | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) |
— | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Vital Signs |
— | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Physical Examination |
— | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Visual Examination |
— | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Audiology |
— | — |
| SECONDARY Minimum Plasma Concentration Between 0 Hour and the Dosing Interval (Tau) (Ctrough) of BDQ and Its Metabolite M2 |
— | — |
| SECONDARY Minimum Plasma Concentration Between 0 Hour and the Dosing Interval (Tau) (Ctrough) of Clarithromycin and Its Metabolite 4-OH CAM |
— | — |
Eligibility Criteria
Inclusion Criteria
- Has body weight greater than or equal to (>=) 40 kilograms (kg) at screening and on Day 1
- Has radiological evidence consistent with nontuberculous mycobacterial lung disease (NTM-LD) based on a chest Computed Tomography (CT) scan taken within 6 months prior to screening or at screening
- Has at least 2 positive sputum cultures of Mycobacterium avium complex (MAC) (sputum cultures to be taken at least 4 weeks apart): one obtained within 12 months prior to screening, which was documented while being treated for Mycobacterium avium complex lung disease (MAC-LD) for a total of at least 6 months; and one at screening (by central microbiology laboratory)
- Received at least 6 months of consecutive MAC-LD treatment (at least 2 antibiotics for MAC, including a macrolide), that is either ongoing or has stopped within 12 months prior to screening
- No presence of cognitive dysfunction that would impact the completion of the patient reported outcome (PRO) assessments
Exclusion Criteria
- Had previous exposure to bedaquiline (BDQ)
- Has active Tuberculosis (TB) disease
- Has cystic fibrosis, medically unstable respiratory disease (for example, chronic obstructive pulmonary disease, bronchiectasis, asthma)
- Has one or more cavities >=2 centimeter (cm) in diameter on a chest CT scan taken within 6 months prior to screening or at screening
- Treatment already includes an injectable/inhaled aminoglycoside within 3 months prior to screening or the investigator deems the participant to be a candidate for an injectable/inhaled aminoglycoside during screening period or at Day 1
Data sourced from ClinicalTrials.gov (NCT04630145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.