Clinical Trial: Mycobacterium Avium Intracellulare Complex (MAC) Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Pilot Study to Assess Safety and Efficacy of Short Course Multiple Drug Therapy for Adult Patients With Mycobacterium Avium Intracellulare Complex (MAC) Infection Associat

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 and assess quality of life measures with MAC disease.

Detailed Summary:

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 bronchiectasis and multiple small nodules. We propose to evaluate the clinical and radiographic response, assess whether macrolide (either Clarithromycin or Azithromycin) resistance develops, and assess quality of life measures.

No evidence of efficacy is required to proceed to longer term studies; however, we will need to confirm lack of development of macrolide resistance in this pilot study before proceeding to any additional studies to evaluate the efficacy of short course MAC treatment.

Once we have demonstrated the feasibility of short course therapy and confirm that resistance to macrolides does not develop, we hope to apply for external funding to support a longer term randomized controlled trial comparing "standard" MAC therapy (which usually consists of a period of eighteen to twenty-four months with at least three antimicrobials) to short course (three months) MAC antimicrobial treatment, alternating each year with nine months of non-MAC bronchial hygiene measures for two consecutive years. If a larger study confirms efficacy of this approach, we would then propose even larger multi-site studies to test the hypothesis that short course MAC therapy alternating every year with non-MAC bronchial hygiene therapy should be considered in all adult patients with MAC pulmonary disease associated with multifocal bronchiectasis and multiple small nodules throughout their lives.

The longer term goal of this research is to develop an optimal treatment strategy for these patients (in whom MAC will likely persist indefinitely) that will result in not only a better quality of li
Sponsor: Mayo Clinic

Current Primary Outcome:

Original Primary Outcome:

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Information By: Mayo Clinic

Dates:
Date Received: January 20, 2009
Date Started: June 2008
Date Completion:
Last Updated: July 27, 2012
Last Verified: July 2012