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Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis

Primary Purpose

Histoplasmosis, Sporotrichosis, Blastomycosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
fluconazole
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Histoplasmosis focused on measuring blastomycosis, fungal infection, histoplasmosis, immunologic disorders and infectious disorders, rare disease, sporotrichosis

Eligibility Criteria

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

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinical, radiographic, nuclear medicine, or similar study findings compatible with active infection with any of the following: Histoplasma capsulatum Blastomyces dermatiditis Sporothrix schenckii At least 1 positive culture within 8 weeks prior to entry Diagnostic histopathology fulfills requirement if confirmed by second independent reviewer Sporotrichosis, i.e.: Ulcerocutaneous disease limited to local or regional skin and lymphatics OR Deep infection of tissue or sites other than locoregional skin/lymphatics Histoplasmosis and blastomycosis with acute pulmonary infection as sole site of disease eligible only if progressive, i.e.: Clinically or radiographically apparent new lesions or continued increase in old lesions for more than 20 days after acute illness onset Positive culture or histopathology at least 20 days after illness onset Relapsed disease eligible, as follows: Clinical evidence of active disease Positive culture within 8 weeks prior to entry Histopathologic evidence alone not acceptable for entry No more than 3 days of systemic amphotericin B or ketoconazole since positive culture Infection site present at study entry, i.e., no prior surgical removal No active meningeal or central nervous system infection Diagnostic tests required if symptomatic No immediately life-threatening infection --Patient Characteristics-- Life expectancy: At least 1 week Hepatic: AST and ALT no greater than 5 times normal Alkaline phosphatase no greater than 5 times normal Bilirubin no greater than 5 times normal PT no greater than 5 seconds above normal or control and not corrected with vitamin K Other: No HIV infection No AIDS (Centers for Disease Control and Prevention criteria) No requirement for any of the following: Barbiturates Phenytoin Oral hypoglycemics Coumarin-type anticoagulants No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 8, 2006
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID), University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004808
    Brief Title
    Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1991 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID), University of Alabama at Birmingham

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Identify a preferred oral fluconazole dose regimen for patients with non-acute histoplasmosis or blastomycosis, or ulcerocutaneous or deep sporotrichosis. II. Study the safety and efficacy of fluconazole in these patients.
    Detailed Description
    PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution and type of infection. Patients with blastomycosis are randomly assigned to moderate- versus high-dose oral fluconazole. Based on clinical response, the dose is increased at 1 and 2 months for patients in the moderate-dose group. Patients in the high-dose group receive a fixed dose of fluconazole. Patients with histoplasmosis and sporotrichosis are nonrandomly treated with moderate-dose fluconazole. Therapy is administered daily for 3 months beyond stabilization of infection (maximum 24 months), or for a total of 6 months if the infection stabilizes within 3 months. Fluconazole may be administered intravenously (maximum 7 days) if the oral dose is not tolerated. Concurrent systemic or intrathecal antifungals, immunostimulants, and lymphocyte replacement are prohibited. Investigational agents or approved agents given for investigational indications are also not permitted on study. Patients are followed at 3, 6, and 12 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Histoplasmosis, Sporotrichosis, Blastomycosis
    Keywords
    blastomycosis, fungal infection, histoplasmosis, immunologic disorders and infectious disorders, rare disease, sporotrichosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    78 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    fluconazole

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinical, radiographic, nuclear medicine, or similar study findings compatible with active infection with any of the following: Histoplasma capsulatum Blastomyces dermatiditis Sporothrix schenckii At least 1 positive culture within 8 weeks prior to entry Diagnostic histopathology fulfills requirement if confirmed by second independent reviewer Sporotrichosis, i.e.: Ulcerocutaneous disease limited to local or regional skin and lymphatics OR Deep infection of tissue or sites other than locoregional skin/lymphatics Histoplasmosis and blastomycosis with acute pulmonary infection as sole site of disease eligible only if progressive, i.e.: Clinically or radiographically apparent new lesions or continued increase in old lesions for more than 20 days after acute illness onset Positive culture or histopathology at least 20 days after illness onset Relapsed disease eligible, as follows: Clinical evidence of active disease Positive culture within 8 weeks prior to entry Histopathologic evidence alone not acceptable for entry No more than 3 days of systemic amphotericin B or ketoconazole since positive culture Infection site present at study entry, i.e., no prior surgical removal No active meningeal or central nervous system infection Diagnostic tests required if symptomatic No immediately life-threatening infection --Patient Characteristics-- Life expectancy: At least 1 week Hepatic: AST and ALT no greater than 5 times normal Alkaline phosphatase no greater than 5 times normal Bilirubin no greater than 5 times normal PT no greater than 5 seconds above normal or control and not corrected with vitamin K Other: No HIV infection No AIDS (Centers for Disease Control and Prevention criteria) No requirement for any of the following: Barbiturates Phenytoin Oral hypoglycemics Coumarin-type anticoagulants No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William Dismukes
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis

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