Overview

This trial is active, not recruiting.

Condition mycobacterium avium complex
Treatment azithromycin, rifabutin
Phase phase 4
Sponsor The University of Texas Health Science Center at Tyler
Collaborator Pfizer
Start date December 1994
End date November 2010
Trial size 58 participants
Trial identifier NCT00598962, 426

Summary

To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex

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, rifabutin 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 - Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver enzymes), hearing test, visual acuity and color discrimination - Available for long term followup Exclusion Criteria: - History of macrolide or rifamycins allergy - Laboratory evidence of mycobacterial resistance to azithromycin - Children less than 18 years of age - If a menstruating female, not pregnant and on adequate birth control - HIV+ or at risk

Additional Information

Official title Open, Noncomparative Trial of Multidrug Regimens Containing Azithromycin and Rifabutin Administered Three Times Per Week for 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.