Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Mycobacterium Avium Complex Lung Disease

Treatments: Drug: clarithromycin, rifabutin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00598897

447

Details and patient eligibility

About

To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week

Full description

Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet American Thoracic Society criteria for nontuberculous mycobacterial lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; absence of other potential mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus).
• Adults age 18 and older
• Pretreatment isolate of M. avium complex available for MIC determination

Exclusion criteria

• History of allergy to study drugs
• If a mensruating female, not pregnant and on adequate birth control.
• Children less than 18 years of age
• HIV + or at high risk for HIV infection.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

clarithromycin and rifabutin/rifampin

Experimental group

Description:

Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly.

Treatment:

Drug: clarithromycin, rifabutin