Intermittent versus daily therapy for nodular bronchiectatic Mycobacterium avium complex lung disease (iREC)

JRCT ID: jRCTs031190008

Registered date:15/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Mycobacterial avium complex lung disease
• Date of first enrollment: 31/05/2019
• Target sample size: 140
• Study type: Interventional

Intervention(s)

arm A (intermittent therapy): clarithromycin 1000mg in diveded doses, ethambutol 25mg/kg (maximum 1000mg), and rifampin 600mg three times weekly (Monday, Wednesday, Friday).
arm B (daily therapy): clarithromycin 800mg in diveded doses, ethambutol 15mg/kg (maximum 750mg), and rifampin 450mg daily.

Outcome(s)

• Primary Outcome: proportion of patients requiring primary regimen modification
• Secondary Outcome: 1) adverse events 2) sputum culture conversion 3) time to sputum culture conversion 4) improvement of chest CT findings 5) improvement of health related QOL 6) development of clarithromycin resistance

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both
• Include criteria: 1) Diagnosed with nodular bronchiectatic Mycobacterium avium complex lung disease according to the 2007 ATS/IDSA guidelines 2) no history of previous treatment of Mycobacrterium avium complex lung disease 3) absence of cavitation on chest CT regardless of size 4) absence of severe symptoms (fever>=38 degrees, mMRC dyspnea score>=2, or active hemoptysis) 5) clinically judged to be suitable for treatment initiation by the attending physician 6) 20 to 80 years of age, defined at the time of acquiring consent 7) Body weights 30kg or more 8) ECOG PS 0-2 9) Adequate organ function. Correspond to the following values in laboratory tests performed at screening Neutrophil count >= 500/mm3 AST, ALT <= three times upper limit of normal Total bilirubin <= 2 times upper limit of normal Creatinine <= 2 times upper limit of normal 10) Written informed consent
• Exclude criteria: 1) Patients whose MAC infection is highly resistant to clarithromycin (MIC>=32) in drug susceptibility testing 2) HIV antibody positive at the time of screening 3) Disseminated MAC infection 4) Patients with cystic fibrosis 5) Patients with active tuberculosis or other serious complications difficult to control (such as malignant tumor, unstable angina, myocardial infarction, and psychiatric disease) 6) Women who are pregnant, possibly pregnant, or unwilling to practice contraception during the study 7) known hypersensitivity to clarithromycin, rifampicin, or ethambutol 8) Patients taking drugs contraindicated to combine with clarithromycin or rifampicin 9) Patients judged not to start ethambtol by the ophthalmologist at screening 10) Patients who showed QT prolongation (QTc>=450 ms) by electrocardiography at screening 11) Judged not to be eligible by the principal investigator/sub-investigators

Related Information

• Primary Sponsor: Nakagawa Taku
• Source(s) of Monetary Support: National Hospital Organization