The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
Completed
NCT Number: NCT00599079
Azithromycin in the Treatment of M. Avium Complex Lung Disease
To determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
About this study
To study the safety and efficacy of azithromycin in combination treatment for M. abscessus and MAC lung disease
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Azithromycin
DrugAzithromycin Daily Dosage dependent on clinical factos such as age, weight and patient specific health descriptors
Other names: Zithromax
Primary outcomes
-
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
Time frame: 6 months
neg cultures X3( sputum conversion)
Secondary outcomes
-
Microbiological cultures
Time frame: 1yr
culture neg 1 yr on treatment
Sponsors and collaborators
Lead sponsor
The University of Texas Health Science Center at Tyler
Other
Collaborators
- Pfizer
Registry information
Official study title
Open, Noncomparative Trial of Azithromycin in the Treatment of M.Avium Complex (MAC) Lung Disease
Important dates
- Study start
- 1993
- Primary completion
- 2008
- Study completion
- 2017
- First posted
- Jan 23, 2008
- Registry last updated
- May 23, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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