Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis
OBJECTIVE: I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral sporotrichosis...
Brief Summary
OBJECTIVE:
I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral sporotrichosis.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
Detailed Clinical Trial Description
PROTOCOL OUTLINE:
Patients are treated with daily oral fluconazole for up to 24 months. Follow-up continues for at least 1 year.
Intervention(s) in this Clinical Trial
- Drug: fluconazole
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: National Institute of Allergy and Infectious Diseases (NIAID) NIH
Overall Clinical Trial Officials and Contacts
William Dismukes Study Chair University of Alabama at Birmingham
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00004938
Study ID Number: 199/11815
ClinicalTrials.gov Identifier: NCT00004938
Health Authority: United States: Federal Government
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00004938
