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

COMPLETEDPHASE4

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

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

NCT00598962•The University of Texas Health Science Center at Tyler

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Key Dates

Start Date

December 1, 1994

Primary Completion Date

November 1, 2006

Completion Date

May 18, 2017

Last Updated

May 23, 2017

Enrollment

ACTUAL participants

Conditions

Mycobacterium Avium Complex

Interventions

Azithromycin

DRUG

Rifabutin/rifampin

DRUG

Drug Exposure and Minimum Inhibitory Concentration in the Treatment of MAC Lung Disease

NCT05824988

Mycobacterium Avium ComplexMycobacterium Avium-Intracellulare Infection+2 more

View study

COMPLETEDPHASE4

Azithromycin in the Treatment of M. Avium Complex Lung Disease

NCT00599079

Mycobacterium Avium Complex Lung Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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