Title
Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
Open Study of Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
Phase
Phase 4Lead Sponsor
University of Texas, TylerStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Nontuberculous Mycobacteria Mycobacterium Avium ComplexIntervention/Treatment
clarithromycin ...Study Participants
210Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria
Oral clarithromycin for treatment of MAC and other nontuberculous mycobacteria in adults with clinical history
Dosage dependent on clinical factors such as age, weight and patient-specific health status
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