Azithromycin in the Treatment of M. Avium Complex Lung Disease
- Registration Number
- NCT00599079
- Brief Summary
To determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease.
- Detailed Description
To study the safety and efficacy of azithromycin in combination treatment for M. abscessus and MAC lung disease
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
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
Exclusion Criteria
- History of macrolide allergy
- Received macrolide therapy in last two months
- Children less than 18 years of age
- If a menstruating female, not pregnant and on adequate birth control
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Azithromycin Azithromycin Azithromycin combined with 2 other drugs given 3 times weekly for MAc lung disease
- Primary Outcome Measures
Name Time Method Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures 6 months neg cultures X3( sputum conversion)
- Secondary Outcome Measures
Name Time Method Microbiological cultures 1yr culture neg 1 yr on treatment
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Tyler
🇺🇸Tyler, Texas, United States