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

Phase 4

Completed

• Conditions: Mycobacterium Avium Complex Lung Disease
• Interventions: Drug: clarithromycin, rifabutin

• Registration Number: NCT00598897
• Lead Sponsor: The University of Texas Health Science Center at Tyler

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

Study Timeline

• Study Start: 1995-08
• Primary Completion: 2002-08-07
• 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: 89

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
clarithromycin and rifabutin/rifampin	clarithromycin, rifabutin	Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly.

Primary Outcome Measures

Name	Time	Method
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures	6 months	sputum conversion culture neg x3

Secondary Outcome Measures

Name	Time	Method
Clinical and microbiological outcomes	1 yr	culture neg 1 yr on treatment

Trial Locations

Locations (1)

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