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Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease

Primary Purpose

Mycobacterium Avium-intracellulare Infection

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
amithiozone
clarithromycin
ethambutol
rifampin
streptomycin
Sponsored by
National Jewish Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycobacterium Avium-intracellulare Infection focused on measuring bacterial infection, immunologic disorders and infectious disorders, mycobacterium avium infection, mycobacterium infection, rare disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Progressive pulmonary disease due to Mycobacterium avium complex (MAC) as defined by: Three of more sputum culture(s) positive for MAC Change in serial chest roentgenograms consistent with active mycobacterial disease over a 12 week period No other obvious cause of pulmonary disease Patients must have organisms that are: Susceptible to amithiozone AND Susceptible or moderately susceptible to the combination of rifampin and ethambutol, and to clarithromycin and streptomycin --Prior/Concurrent Therapy-- No likelihood of resectional thoracic surgery within 24 weeks of evaluation --Patient Characteristics-- Age: 18 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 times normal SGOT/SGPT less than 3 times normal Alkaline phosphatase less than 3 times normal Renal: Creatinine clearance at least 30 mL/min Cardiovascular: No New York Heart Association class III or IV heart failure Other: No optic disease that precludes the use of ethambutol No hypersensitivity to rifampin, ethambutol, clarithromycin, streptomycin, or amithiozone HIV negative Not pregnant or nursing

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    March 24, 2015
    Sponsor
    National Jewish Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004689
    Brief Title
    Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 1999
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1991 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 1998 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Jewish Health

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Determine the bacteriological activity of amithiozone against Mycobacterium avium complex (MAC) pulmonary disease. II. Define the ability of amithiozone to improve clinical outcomes in patients with MAC infection. III. Determine the safety and tolerance of amithiozone with chronic dosing in these patients. IV. Assess the contribution of clarithromycin, streptomycin, rifampin, ethambutol, kanamycin, and amithiozone in the treatment of pulmonary MAC infection.
    Detailed Description
    PROTOCOL OUTLINE: The is a randomized, open label study. All patients receive a core regimen of clarithromycin and streptomycin. Patients are randomized into two treatment arms. Arm I patients receive rifampin and ethambutol. Arm II patients receive amithiozone. Patients are followed for one year to detect any relapse or other complications. Patients not eligible for this randomized study may be entered on a short open label study with amithiozone. Completion date provided represents the completion date of the grant per OOPD records

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mycobacterium Avium-intracellulare Infection
    Keywords
    bacterial infection, immunologic disorders and infectious disorders, mycobacterium avium infection, mycobacterium infection, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    amithiozone
    Intervention Type
    Drug
    Intervention Name(s)
    clarithromycin
    Intervention Type
    Drug
    Intervention Name(s)
    ethambutol
    Intervention Type
    Drug
    Intervention Name(s)
    rifampin
    Intervention Type
    Drug
    Intervention Name(s)
    streptomycin

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Progressive pulmonary disease due to Mycobacterium avium complex (MAC) as defined by: Three of more sputum culture(s) positive for MAC Change in serial chest roentgenograms consistent with active mycobacterial disease over a 12 week period No other obvious cause of pulmonary disease Patients must have organisms that are: Susceptible to amithiozone AND Susceptible or moderately susceptible to the combination of rifampin and ethambutol, and to clarithromycin and streptomycin --Prior/Concurrent Therapy-- No likelihood of resectional thoracic surgery within 24 weeks of evaluation --Patient Characteristics-- Age: 18 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 3 times normal SGOT/SGPT less than 3 times normal Alkaline phosphatase less than 3 times normal Renal: Creatinine clearance at least 30 mL/min Cardiovascular: No New York Heart Association class III or IV heart failure Other: No optic disease that precludes the use of ethambutol No hypersensitivity to rifampin, ethambutol, clarithromycin, streptomycin, or amithiozone HIV negative Not pregnant or nursing
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charles Arthur Peloquin
    Organizational Affiliation
    National Jewish Health
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease

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