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Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

Sponsor
The University of Texas Health Science Center at Tyler (Other)
Overall Status
Completed
CT.gov ID
NCT03164291
Collaborator
Pfizer (Industry)
170
Enrollment
1
Location
1
Arm
395.5
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
170 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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 Start Date :
Jun 1, 1984
Actual Primary Completion Date :
Sep 1, 2006
Actual Study Completion Date :
May 18, 2017

Arms and Interventions

Arm Intervention/Treatment
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)

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical and microbiological outcomes (e.g. clinical symptoms, laboratory cultures) [6 mos]

      neg cultures X3( sputum conversion)

    Secondary Outcome Measures

    1. Microbiological Cultures [1year]

      neg cultures for 1 yr on treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas Health Science Center at Tyler Tyler Texas United States 75708

    Sponsors and Collaborators

    • The University of Texas Health Science Center at Tyler
    • Pfizer

    Investigators

    • Principal Investigator: Richard J Wallace, Jr, M.D., The University of Texas Health Center at Tyler
    • Study Chair: William B Girard, MD, University of Texas Health Science Center IRB Chair

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Richard J. Wallace, Jr., M.D., Chairman Department of Microbiology, The University of Texas Health Science Center at Tyler
    ClinicalTrials.gov Identifier:
    NCT03164291
    Other Study ID Numbers:
    • 072
    First Posted:
    May 23, 2017
    Last Update Posted:
    May 23, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Richard J. Wallace, Jr., M.D., Chairman Department of Microbiology, The University of Texas Health Science Center at Tyler
    MAC and NTM
    Additional relevant MeSH terms:
    Infections
    Mycobacterium Infections
    Mycobacterium avium-intracellulare Infection
    Rifabutin

    Study Results

    No Results Posted as of May 23, 2017