Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

Overview

Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections who have failed or are intolerant of rifampin. Rifabutin may be a reasonable alternative agent in patients who fail rifampin or or intolerant of rifampin.

Full Title of Study: “Clinical Efficacy of Rifabutin in the Treatment of Serious and Life Threatening Infections Due to Mycobacterium Avium Complex, or Drug Resistant Mycobacterium Tuberculosis, or Other Drug Resistant Mycobacterium”

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: September 2006

Detailed Description

Rifabutin dosage 150-300 mg daily( depending upon age, and clinical conditions) in NTM patients who fail treatment with rifampin.

Interventions

  • Drug: Rifabutin
    • Rifabutin dosage dependent on clinical factors such as age, weight, and patient-specific health status

Arms, Groups and Cohorts

  • Experimental: Rifabutin
    • Treatment of adults with chronic Mycobacterium avium-intracellulare complex lung infections or other NTM disease who fail therapy with other drugs ( i.e., rifampin)

Clinical Trial Outcome Measures

Primary Measures

  • Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures)
    • Time Frame: 6 mos
    • neg cultures X3( sputum conversion)

Secondary Measures

  • Microbiological Cultures
    • Time Frame: 1year
    • neg cultures for 1 yr on treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Adults age 18 and older with positive acid-fast bacilli smears and cultures for drug-resistant mycobacteria Exclusion Criteria:

  • Children less than 18 years of age – Pregnancy – Low platelet count, except with very serious disease

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
    • Pfizer
  • 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 Center at Tyler
    • William B Girard, MD, Study Chair, University of Texas Health Science Center IRB Chair

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