Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sporotrichosis
Intervention: fluconazole (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID) Official(s) and/or principal investigator(s):
William Dismukes, Study Chair, Affiliation: University of Alabama at Birmingham
Summary
OBJECTIVE:
I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral
sporotrichosis.
Clinical Details
Study design: Treatment, Randomized, Efficacy Study
Detailed description:
PROTOCOL OUTLINE:
Patients are treated with daily oral fluconazole for up to 24 months. Follow-up continues for
at least 1 year.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Related publications: Kauffman CA, Pappas PG, McKinsey DS, Greenfield RA, Perfect JR, Cloud GA, Thomas CJ, Dismukes WE. Treatment of lymphocutaneous and visceral sporotrichosis with fluconazole. Clin Infect Dis. 1996 Jan;22(1):46-50.
Starting date: August 1996
Ending date: August 1996
Last updated: June 8, 2006
|
