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

The University of Texas Health Science Center at Tyler89 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mycobacterium Avium Complex Lung Disease

Interventions

clarithromycin, rifabutinDRUG

Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin or rifampin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Outcomes

Primary Outcomes

Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures

sputum conversion culture neg x3

Time frame: 6 months

Secondary Outcomes

Clinical and microbiological outcomes

culture neg 1 yr on treatment

Time frame: 1 yr

Data from ClinicalTrials.gov

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