Azithromycin in the Treatment of M. Avium Complex Lung Disease

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Mycobacterium Avium Complex Lung Disease

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00599079

340

Details and patient eligibility

About

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

Full description

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

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Azithromycin

Experimental group

Description:

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

Treatment:

Drug: Azithromycin