Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease

Open, Noncomparative Trial of Multidrug Regimens Containing Clarithromycin 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

NCT00598897

Enrollment

Registered

2008-01-23

Start date

1995-08-31

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 Lung Disease

Keywords

MAC

Brief summary

To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week

Detailed description

Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin

Interventions

DRUGclarithromycin, rifabutin

Clarithromycin three times per week (variable dosage) in combination with multiple drugs including rifabutin or rifampin three times per week (variable dosage). Dosage dependent on age, weight and other patient-specific health factors.

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 mycobacterial 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; absence of other potential mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus). * Adults age 18 and older * Pretreatment isolate of M. avium complex available for MIC determination

Exclusion criteria

* History of allergy to study drugs * If a mensruating female, not pregnant and on adequate birth control. * Children less than 18 years of age * HIV + or at high risk for HIV infection.

Design outcomes

Primary

Measure	Time frame	Description
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures	6 months	sputum conversion culture neg x3

Secondary

Measure	Time frame	Description
Clinical and microbiological outcomes	1 yr	culture neg 1 yr on treatment

Countries

United States

Outcome results

None listed

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