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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 7, 2002

Detailed Description

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

Interventions

  • Drug: 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.

Arms, Groups and Cohorts

  • Experimental: clarithromycin and rifabutin/rifampin
    • Clarithromycin and rifabutin/rifampin with ethambutol given three times weekly.

Clinical Trial Outcome Measures

Primary Measures

  • Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
    • Time Frame: 6 months
    • sputum conversion culture neg x3

Secondary Measures

  • Clinical and microbiological outcomes
    • Time Frame: 1 yr
    • culture neg 1 yr on treatment

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The University of Texas Health Science Center at Tyler
  • Collaborator
    • Abbott
  • Provider of Information About this Clinical Study
    • Principal Investigator: Richard J. Wallace, Jr., M.D., Chairman Department of Microbiology – The University of Texas Health Science Center at Tyler
  • Overall Official(s)
    • Richard J Wallace Jr., M.D., Principal Investigator, The University of Texas Health Science Center at Tyler

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