Use of Azithromycin and Rifabutin Administered 3 Times Weekly for the Treatment of M. Avium Complex (MAC) Lung Disease

Study Overview
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Brief Summary
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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
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Azithromycin given 3 times weekly along with rifampin/rifabutin and ethambutol for treatment of MAC

Official Title
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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

Conditions
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Mycobacterium Avium Complex

Intervention / Treatment
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* Drug: Azithromycin
* Drug: Rifabutin/rifampin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: azithromycin and rifabutin/rifampin<br>Azithromycin and rifabutin/rifampin administered three times weekly. | Drug: Azithromycin<br>* Dosage dependent on clinical factors such as age, weight and patient-specific health status<br>* Other names: Zithromax;Drug: Rifabutin/rifampin<br> <br> * Other names: mycobutin/;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures | neg cultures X3 ( sputum conversion) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological cultures | neg culture 1 yr on treatment | 1yr | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MAC