Efficacy and safety of Clarithromycin(CAM)/Ethambutol(EB) versus Rifampicin(RIF)/Clarithromycin(CAM)/Ethambutol(EB) in Mycobacterium avium Complex(MAC): a randomized, open-label, multicenter study

UMIN ID: UMIN000002819

Registered date:01/12/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Mycobacterium avium Complex(MAC) without HIV
• Date of first enrollment: 2006/04/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Body weight is over 40kg. Rifampicin 450mg/day Clarithromycin 600mg/day Ethambutol 750mg/day Body weight is under 40kg. Rifampicin 300mg/day Clarithromycin 400mg/day Ethambutol 500mg/day Duration One year.
Body weight is over 40kg. Clarithromycin 600mg/day Ethambutol 750mg/day Body weight is under 40kg. Clarithromycin 400mg/day Ethambutol 500mg/day Duration One year.

Outcome(s)

• Primary Outcome: chest Xray, HRCT, bacteriologic evaluation, clinical symptom
• Secondary Outcome: the serum and intracellular concentration of Clarithromycin, Clarithromycin resistance of MAC

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: ECOG performance status 3-4. Patients with HIV infection. Patients with history of treatment for MAC infection. Patients with any undelying disease considered tohave a significant impact on the course of treatment in this clinical study such as progressive cancer. Patients receiving immunosuppressive drug.

Related Information

• Primary Sponsor: Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
• Secondary Sponsor: Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
• Source(s) of Monetary Support: National hospital Organization Tenryu Hospital