OBJECTIVE: I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral sporotrichosis...
Date First Received: February 24, 2000
Last Updated: June 8, 2006
Verified by: Office of Rare Diseases (ORD), April 2000
Clinical Trial Phase: Phase 2 | Start Date: August 1996
Overall Status: Completed
Estimated Enrollment: 30
Brief Summary
Condition Keyword(s):
Intervention(s):
OBJECTIVE:
I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral sporotrichosis.
Study Type: Interventional
Study Design: Treatment, Randomized, Efficacy Study
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 Sponsor Information
Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
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 November 18, 2008
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
