Overview

This trial is active, not recruiting.

Conditions mycobacterium avium complex, m. abscessus
Treatment azithromycin
Phase phase 4
Sponsor The University of Texas Health Science Center at Tyler
Collaborator Pfizer
Start date February 1993
End date August 2010
Trial size 66 participants
Trial identifier NCT00599079, 340

Summary

To determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
azithromycin Zithromax
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 three months, then at six 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 three months, then at six 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; 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

Additional Information

Official title Open, Noncomparative Trial of Azithromycin in the Treatment of M.Avium Complex (MAC) Lung Disease
Principal investigator Richard J Wallace Jr., M.D.
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.