Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis

National Institute of Allergy and Infectious Diseases (NIAID)30 enrolled

Overview

OBJECTIVE: I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral sporotrichosis.

PROTOCOL OUTLINE: Patients are treated with daily oral fluconazole for up to 24 months. Follow-up continues for at least 1 year.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Sporotrichosis

Interventions

fluconazoleDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Presumptive evidence of sporotrichosis Culture-proven sporotrichosis determined on study Relapsing disease following antifungal therapy eligible if culture positive for Sporothrix schenckii prior to entry No life-threatening disease No central nervous system sporotrichosis --Prior/Concurrent Therapy-- No concurrent drugs known to react with fluconazole No more than 3 days of systemic antifungals for current sporotrichosis episode --Patient Characteristics-- Hepatic: Liver function tests no greater than 5 times normal Other: No HIV infection No pregnant or nursing women

Data from ClinicalTrials.gov

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