Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis
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.
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.
Primary Purpose: Treatment
Office of Rare Diseases (ORD)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00004808
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Triazole antifungal agent that is used to treat oropharyngeal candidiasis and cryptococcal meningitis in AIDS.
One of the triazole ANTIFUNGAL AGENTS that inhibits cytochrome P-450-dependent enzymes resulting in impairment of ERGOSTEROL synthesis. It has been used against histoplasmosis, blastomycosis, cryptococcal meningitis & aspergillosis.
Infection resulting from inhalation or ingestion of spores of the fungus of the genus HISTOPLASMA, species H. capsulatum. It is worldwide in distribution and particularly common in the midwestern United States. (From Dorland, 27th ed)
A mitosporic Onygenales fungal genus causing HISTOPLASMOSIS in humans and animals. Its single species is Histoplasma capsulatum which has two varieties: H. capsulatum var. capsulatum and H. capsulatum var. duboisii. Its teleomorph is AJELLOMYCES capsulatus.
An inherited condition characterized by multiple malformations of CARTILAGE and bone including CRANIOSYNOSTOSIS; midface hypoplasia; radiohumeral SYNOSTOSIS; CHOANAL ATRESIA; femoral bowing; neonatal fractures; and multiple joint CONTRACTURES and, occasionally, urogenital, gastrointestinal or cardiac defects. In utero exposure to FLUCONAZOLE, as well as mutations in at least two separate genes are associated with this condition - POR (encoding P450 (cytochrome) oxidoreductase (NADPH-FERRIHEMOPROTEIN REDUCTASE)) and FGFR2 (encoding FIBROBLAST GROWTH FACTOR RECEPTOR 2).
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