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

Phase 4

Completed

• Conditions: Mycobacterium Avium Complex
• Interventions: Drug: Azithromycin; Drug: Rifabutin/rifampin

• Registration Number: NCT00598962
• Lead Sponsor: The University of Texas Health Science Center at Tyler

Brief Summary

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

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

Study Timeline

• Study Start: 1994-12
• Primary Completion: 2006-11
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-11
• Study First Posted: 2008-01-23
• Status Verified: 2017-05
• Study Completion: 2017-05-18
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
azithromycin and rifabutin/rifampin	Rifabutin/rifampin	Azithromycin and rifabutin/rifampin administered three times weekly.
azithromycin and rifabutin/rifampin	Azithromycin	Azithromycin and rifabutin/rifampin administered three times weekly.

Primary Outcome Measures

Name	Time	Method
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures	6 months	neg cultures X3 ( sputum conversion)

Secondary Outcome Measures

Name	Time	Method
Microbiological cultures	1yr	neg culture 1 yr on treatment

Trial Locations

Locations (1)

The University of Texas Health Science Center at Tyler; 🇺🇸 Tyler, Texas, United States