Status:
COMPLETED
Mycobacterium Avium Intracellulare Complex (MAC) Study
Lead Sponsor:
Mayo Clinic
Conditions:
Mycobacterium Avium Intracellulare Complex (MAC)
Eligibility:
All Genders
18+ years
Brief Summary
This study is short course (3 month) multiple drug antibiotic therapy. The purpose of this research study is to evaluate the clinical and radiology response to assess whether drug resistance develops ...
Detailed Description
The goal of this pilot study is to assess the safety and efficacy of short course (3 months) multiple drug antimicrobial therapy in adults with MAC pulmonary disease associated with multifocal bronchi...
Eligibility Criteria
Inclusion
- All patients must meet diagnostic criteria for nontuberculous mycobacterial pulmonary disease as per ATS/IDSA Official Statement (AJRCCM Vol 175 pp 367-416, 2007)
- Confirmation both by a chest radiologist and the investigators of multifocal bronchiectasis and multiple small nodules on HRCT scanning of the chest
- Repeatedly positive sputum cultures and/or bronchial washings for MAC (in accordance with microbiologic diagnostic criteria outline by the American Thoracic Society)
- MAC must be proven to be macrolide (either Clarithromycin or Azithromycin) sensitive at the onset of the study
- Age greater than 18
- No active treatment for MAC lung disease within the past two years
- Patients and their physicians must be willing to discontinue other non-MAC antimicrobials which may have been used as part of their pre-study bronchial hygiene program.
Exclusion
- History of Cystic Fibrosis or HIV disease
- Known allergy or intolerance to any of the proposed antibiotics
- Inability to return at three month intervals for testing over the six month study period
- Inability to complete quality of life questionnaires
- Pregnancy
- Presence of any abnormality on baseline ophthalmological examination which would preclude the use of ethambutol.
- Coexistence of non-tuberculous mycobacteria other than MAC
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00826423
Start Date
June 1 2008
End Date
September 1 2011
Last Update
July 30 2012
Active Locations (1)
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1
Mayo Clinic
Jacksonville, Florida, United States, 32224