Overview

This trial is active, not recruiting.

Condition mycobacterium avium complex lung disease
Treatment clarithromycin, rifabutin
Phase phase 4
Sponsor The University of Texas Health Science Center at Tyler
Collaborator Abbott
Start date August 1995
End date July 2010
Trial size 89 participants
Trial identifier NCT00598897, 447

Summary

To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week

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)
clarithromycin, rifabutin Biaxin
Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.

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 at one month, then at three months, then at 6 months, then annually, and prn for life

Secondary Outcomes

Measure
To determine if treatment given three times weekly is as effective in producing sputum culture conversion as treatment given daily
time frame: Monthly while on treatment, then followup after therapy discontinuation at one month, then at three 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 mycobacterial 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 mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus). - Adults age 18 and older - Pretreatment isolate of M. avium complex available for MIC determination Exclusion Criteria: - History of allergy to study drugs - If a mensruating female, not pregnant and on adequate birth control. - Children less than 18 years of age - HIV + or at high risk for HIV infection.

Additional Information

Official title Open, Noncomparative Trial of Multidrug Regimens Containing Clarithromycin 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.