Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis
|ClinicalTrials.gov Identifier: NCT00004808|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 9, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Histoplasmosis Sporotrichosis Blastomycosis||Drug: fluconazole||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Study Start Date :||September 1991|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004808
|Study Chair:||William Dismukes||University of Alabama at Birmingham|