Azithromycin in the Treatment of M. Avium Complex 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; M. Abscessus
Intervention: Azithromycin (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 efficacy of azithromycin in the treatment of lung infection with
M. avium complex and M. abscessus lung disease.
Clinical Details
Official title: Open, Noncomparative Trial of Azithromycin in 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: Microbiological cultures
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
The University of Texas Health Science Center at Tyler, Tyler, Texas 75708, United States
Additional Information
Starting date: February 1993
Last updated: January 11, 2008
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