NCT00004808

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Histoplasmosis
• Sporotrichosis
• Blastomycosis

Interventions

Type	Name	Description
DRUG	fluconazole

Timeline

• Start date: 1991-09-01
• First posted: 2000-02-25
• Last updated: 2006-06-09