Mycobacterium Avium Complex, Nontuberculous Mycobacteria
Conditions
Keywords
MAC, NTM
Brief summary
Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria
Detailed description
Oral clarithromycin for treatment of MAC and other nontuberculous mycobacteria in adults with clinical history
Interventions
DRUGClarithromycin
Dosage dependent on clinical factors such as age, weight and patient-specific health status
Sponsors
Abbott
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; absence of other potential lung pathogens (except for the coexistence of M. abscessus) * Age 18 years and older
Exclusion criteria
* History of macrolide allergy * Must not receive the antihistamines terfenadine (Seldane) or astemizole (Hismanal) while on clarithromycin * 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 culture x3( sputum conversion) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological cultures | 1yr | neg culture for 1 yr on treatment |
Countries
United States
Outcome results
None listed