Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease
Information source: The University of Texas Health Science Center at Tyler
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycobacterium Avium Complex Lung Disease
Intervention: clarithromycin, rifabutin (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: The University of Texas Health Science Center at Tyler Official(s) and/or principal investigator(s):
Richard J Wallace Jr., M.D., Principal Investigator, Affiliation: The University of Texas Health Science Center at Tyler
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
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
Secondary outcome: To determine if treatment given three times weekly is as effective in producing sputum culture conversion as treatment given daily
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
The University of Texas Health Science Center at Tyler, Tyler, Texas 75708, United States
Additional Information
Starting date: August 1995
Last updated: January 11, 2008
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