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

• Status: Completed
• Trial end date: 2017-05-18
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at Tyler
• Collaborators: Abbott; Pfizer
• Treatments: Clarithromycin; Rifabutin

Criteria

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.