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

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 - 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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002819

Enrollment

100

Registered

2009-12-01

Start date

2006-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycobacterium avium Complex(MAC) without HIV

Interventions

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 Du

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Meeting diagnostic criteria for MAC infection described in "Am J Respir Crit Care Med Vol.175. p367-416". Written informed consent obtained.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
chest Xray, HRCT, bacteriologic evaluation, clinical symptom	—

Secondary

Measure	Time frame
the serum and intracellular concentration of Clarithromycin, Clarithromycin resistance of MAC	—

Countries

Japan

Contacts

Public ContactMasahiro shirai

National hospital Organization Tenryu Hospital respiratory medicine

shiraim@smail.plala.or.jp053-583-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026