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

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Mycobacterium Avium Complex

Treatments: Drug: Azithromycin; Drug: Rifabutin/rifampin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00598962

426

Details and patient eligibility

About

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)

Full description

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

Enrollment: 58 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
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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58 participants in 1 patient group

azithromycin and rifabutin/rifampin

Experimental group

Description:

Azithromycin and rifabutin/rifampin administered three times weekly.

Treatment:

Drug: Rifabutin/rifampin

Drug: Azithromycin