Use of Azithromycin and Rifabutin Administered 3 Times Weekly 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 efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex(MAC)

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

Details

• Lead Sponsor: The University of Texas Health Science Center at Tyler
• Collaborator: Pfizer
• Treatments: Azithromycin; Rifabutin; Rifampin

Criteria

Inclusion Criteria:

• Meet American Thoracic Society criteria for nontuberculous 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; abnormal CXR consistent with M. avium lung disease; absence of other lung pathogens (except for the coexistence of M. abscessus).

• Age 18 and older

• Pretreatment isolate of M. avium complex available for MIC determination

• Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver enzymes), hearing test, visual acuity and color discrimination

• Available for long term followup

Exclusion Criteria:

• History of macrolide or rifamycins allergy

• Laboratory evidence of mycobacterial resistance to azithromycin

• Children less than 18 years of age

• If a menstruating female, not pregnant and on adequate birth control

• HIV+ or at risk