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

NCT ID: NCT00598962

Last Updated: 2017-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-12-31
• Study Completion Date: 2017-05-18

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

Conditions

Mycobacterium Avium Complex

Study Design

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

Study Groups

azithromycin and rifabutin/rifampin

Azithromycin and rifabutin/rifampin administered three times weekly.

Group Type: EXPERIMENTAL

Azithromycin

Intervention Type: DRUG

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

Rifabutin/rifampin

Intervention Type: DRUG

Interventions

Azithromycin

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

Intervention Type: DRUG

Rifabutin/rifampin

Intervention Type: DRUG

Other Intervention Names

Zithromax; mycobutin/

Eligibility Criteria

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

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

Sponsors

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

426

Identifier Type: -

Identifier Source: org_study_id