Azithromycin in the Treatment of M. Avium Complex Lung Disease
NCT00599079
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Azithromycin in the Treatment of M. Avium Complex Lung Disease | |||
Official Title ICMJE | Open, Noncomparative Trial of Azithromycin in the Treatment of M.Avium Complex (MAC) Lung Disease | |||
Brief Summary | To determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease. | |||
Detailed Description | To study the safety and efficacy of azithromycin in combination treatment for M. abscessus and MAC lung disease | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Mycobacterium Avium Complex Lung Disease | |||
Intervention ICMJE | Drug: Azithromycin
Azithromycin Daily Dosage dependent on clinical factos such as age, weight and patient specific health descriptors Other Name: Zithromax | |||
Study Arms ICMJE | Experimental: Azithromycin
Azithromycin combined with 2 other drugs given 3 times weekly for MAc lung disease Intervention: Drug: Azithromycin | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 66 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 18, 2017 | |||
Actual Primary Completion Date | May 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00599079 | |||
Other Study ID Numbers ICMJE | 340 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Richard J. Wallace, Jr., M.D., The University of Texas Health Science Center at Tyler | |||
Study Sponsor ICMJE | The University of Texas Health Science Center at Tyler | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | The University of Texas Health Science Center at Tyler | |||
Verification Date | May 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |