Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
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: Non-Tuberculous Mycobacteria; Mycobacterium Avium Complex
Intervention: Clarithromycin (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: The University of Texas Health Science Center at Tyler
Summary
Use of oral clarithromycin for treatment of chronic lung disease due to Mycobacterium
avium-intracellulare and other non-tuberculous Mycobacteria
Clinical Details
Official title: Open Study of Clarithromycin for the Treatment of Infections Caused by Nontuberculous Mycobacteria (NTM)
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, 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; absence of other potential lung
pathogens (except for the coexistence of M. abscessus)
- Age 18 years and older
Exclusion Criteria:
- History of macrolide allergy
- Must not receive the antihistamines terfenadine (Seldane) or astemizole (Hismanal)
while on clarithromycin
- 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: January 1991
Last updated: January 14, 2008
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