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

NCT ID: NCT00598897

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-08-31
• Study Completion Date: 2017-05-18

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

Conditions

Mycobacterium Avium Complex Lung Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

clarithromycin and rifabutin/rifampin

Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly.

Group Type: EXPERIMENTAL

clarithromycin, rifabutin

Intervention Type: DRUG

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.

Interventions

clarithromycin, 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.

Intervention Type: DRUG

Other Intervention Names

Biaxin, mycobutin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center at Tyler

OTHER

Sponsor Role: lead

Responsible Party

Richard J. Wallace, Jr., M.D.

Chairman Department of Microbiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard J Wallace Jr., M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at Tyler

Locations

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Countries

United States

Other Identifiers

447

Identifier Type: -

Identifier Source: org_study_id