Mycobacterium Avium Complex Lung Disease
Conditions
Keywords
MAC
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
Interventions
DRUGAzithromycin
Azithromycin Daily Dosage dependent on clinical factos such as age, weight and patient specific health descriptors
Sponsors
Pfizer
The University of Texas Health Science Center at Tyler
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures | 6 months | neg cultures X3( sputum conversion) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological cultures | 1yr | culture neg 1 yr on treatment |
Countries
United States
Outcome results
None listed