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Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00004938
Enrollment
30
Registered
2000-02-25
Start date
1996-08-31
Completion date
1996-08-31
Last updated
2006-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sporotrichosis

Keywords

fungal infection, rare disease, sporotrichosis

Brief summary

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

Detailed description

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

Interventions

DRUGfluconazole

Sponsors

University of Alabama at Birmingham
CollaboratorOTHER
National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026