Mycobacterium Avium Intracellulare Complex (MAC) Study

Completed

Conditions studied: Mycobacterium Avium Intracellulare Complex (MAC)

In brief

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 and assess quality of life measures with MAC disease.

Key facts

Study ID

NCT00826423

Run by

Mayo Clinic

People needed

15

Starts

2008-06-01

Expected to finish

2011-09-01

Last updated by the study team

2012-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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