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

Last updated: May 19, 2017
Sponsor: The University of Texas Health Science Center at Tyler
Overall Status: Completed

Phase

4

Condition

Mac Infection (Mycobacterium Avium Complex)

Treatment

N/A

Clinical Study ID

NCT00598897
447
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet American Thoracic Society criteria for nontuberculous mycobacterial lung disease:two or more AFB smear positive, culture positive sputums or bronchoscopic samplesand/or two or more AFB smear negative respiratory samples with moderate to heavygrowth (2+-4+); abnormal CXR consistent with M. avium lung disease; absence of otherpotential 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

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

Total Participants: 89
Study Start date:
August 01, 1995
Estimated Completion Date:
May 18, 2017

Study Description

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

Connect with a study center

  • The University of Texas Health Science Center at Tyler

    Tyler, Texas 75708
    United States

    Site Not Available

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