JPRN-jRCT2031200268
Recruiting
Phase 2
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)
akama Takahiro0 sites124 target enrollmentDecember 24, 2020
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- akama Takahiro
- Enrollment
- 124
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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 creening
- •\- 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
Outcomes
Primary Outcomes
Not specified
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