Azithromycin in the Treatment of M. Avium Complex Lung Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-02-28

Study Completion Date

2017-05-18

Brief Summary

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To determine the safety and efficacy of azithromycin in the treatment of lung infection with M.avium complex and M. abscessus lung disease.

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Detailed Description

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To study the safety and efficacy of azithromycin in combination treatment for M. abscessus and MAC lung disease

Conditions

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Mycobacterium Avium Complex Lung Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azithromycin

Azithromycin combined with 2 other drugs given 3 times weekly for MAc lung disease

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

Azithromycin Daily Dosage dependent on clinical factos such as age, weight and patient specific health descriptors

Interventions

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Azithromycin

Azithromycin Daily Dosage dependent on clinical factos such as age, weight and patient specific health descriptors

Intervention Type DRUG

Other Intervention Names

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Zithromax

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

Exclusion Criteria

* History of macrolide allergy
* Received macrolide therapy in last two months
* Children less than 18 years of age
* If a menstruating female, not pregnant and on adequate birth control

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No