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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00598962

Enrollment

Registered

2008-01-23

Start date

1994-12-31

Completion date

2017-05-18

Last updated

2017-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mycobacterium Avium Complex

Keywords

MAC

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

Interventions

DRUGAzithromycin

Dosage dependent on clinical factors such as age, weight and patient-specific health status

DRUGRifabutin/rifampin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures	6 months	neg cultures X3 ( sputum conversion)

Secondary

Measure	Time frame	Description
Microbiological cultures	1yr	neg culture 1 yr on treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026