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

Phase 3

• Conditions: Mycobacterial avium complex lung disease; D015270

• Registration Number: JPRN-jRCTs031190008
• Lead Sponsor: akagawa Taku

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 140

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified