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Open randomized controlled trial to evaluate efficacy of clindamycin in the pulmonary Mycobacterium avium complex disease

Open randomized controlled trial to evaluate efficacy of clindamycin in the pulmonary Mycobacterium avium complex disease - Open randomized controlled trial to evaluate efficacy of clindamycin in the pulmonary Mycobacterium avium complex disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016615
Enrollment
100
Registered
2015-02-23
Start date
2015-02-24
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

Pulmonary Mycobacterium avium complex disease

Interventions

Oral administration of clarithromycin, rifampicin, ethambutol. After oral administration of clarithromycin, rifampicin, ethambutol for month, add oral administration of clindamycin for two months. F

Sponsors

Department of Respiratory Medicine, University of Occupational and Environmental Health, Japan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients 20 years of age and older 2. Patients satisfying diagnostic riteria of nontuberculous mycobacteriosis and causative pathogens are Mycobacterium avium or M. intracellulare

Exclusion criteria

Exclusion criteria: 1. Patients receiving other antibiotic treatments. 2. Contraindication for clindamycin, clarithromycin, rifampicin, ethambutol administration 3. Patients deemed ineligible by the attending physicians for various reasons. 4. Patients with serious heart disorders

Design outcomes

Primary

MeasureTime frame
Findings of chest high resolution computed tomography before and after clindamycin treatment

Secondary

MeasureTime frame
1. Symptoms, laboratory data, spirometry 2. Bacteriological efficacy: sputum culture, and bacterial floral analysis findings of bronchoalveolar lavage fluid culture 3. Safety and adverse effects of clindamycin treatment

Countries

Japan

Contacts

Public ContactKei Yamasaki

University of Occupational and Environmental Health, Japan Department of Respiratory Medicine

kkyamsaki1019@yahoo.co.jp093-603-1611

Outcome results

None listed

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