Overview

This trial is active, not recruiting.

Conditions non-tuberculous mycobacteria, mycobacterium avium complex
Treatment clarithromycin
Phase phase 4
Sponsor The University of Texas Health Science Center at Tyler
Collaborator Abbott
Start date January 1991
End date November 2010
Trial size 210 participants
Trial identifier NCT00600769, 263

Summary

Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium avium-intracellulare and other non-tuberculous Mycobacteria

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
clarithromycin Biaxin
Dosage dependent on clinical factors such as age, weight and patient-specific health status

Primary Outcomes

Measure
Clinical and microbiological outcomes, such as clinical symptoms and laboratory cultures
time frame: Monthly while on treatment, then followup after therapy discontinuation will be at one month, then at 3 months, then at 6 months, then annually, and prn for life

Secondary Outcomes

Measure
Microbiological cultures
time frame: Monthly while on treatment, then followup after therapy discontinuation will be at one month, then at 3 months, then at 6 months, then annually, and prn for life

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Open Study of Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
Trial information was received from ClinicalTrials.gov and was last updated in January 2008.
Information provided to ClinicalTrials.gov by The University of Texas Health Science Center at Tyler.