Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease
NCT00598962
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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
- Baseline laboratory and clinical testing for baseline CBC, Chemistry (including liver enzymes), hearing test, visual acuity and color discrimination
- Available for long term followup
- History of macrolide or rifamycins allergy
- Laboratory evidence of mycobacterial resistance to azithromycin
- Children less than 18 years of age
- If a menstruating female, not pregnant and on adequate birth control
- HIV+ or at risk
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Descriptive Information | ||||
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Brief Title ICMJE | Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease | |||
Official Title ICMJE | Open, Noncomparative Trial of Multidrug Regimens Containing Azithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease | |||
Brief Summary | To determine the safety and efficacy of azithromycin, rifabutin and ethambutol given three times weekly in the treatment of lung infection with M. avium complex(MAC) | |||
Detailed Description | Azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of MAC | |||
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 | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: azithromycin and rifabutin/rifampin
Azithromycin and rifabutin/rifampin administered three times weekly. Interventions:
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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 | 58 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 18, 2017 | |||
Actual Primary Completion Date | November 2006 (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 | NCT00598962 | |||
Other Study ID Numbers ICMJE | 426 | |||
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 |