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Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004938
First Posted: February 25, 2000
Last Update Posted: June 9, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Alabama at Birmingham
Information provided by:
Office of Rare Diseases (ORD)
February 24, 2000
February 25, 2000
June 9, 2006
August 1996
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Complete list of historical versions of study NCT00004938 on ClinicalTrials.gov Archive Site
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Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis
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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.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Sporotrichosis
Drug: fluconazole
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 1996
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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

Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00004938
199/11815
NIAID-MSG-11815
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National Institute of Allergy and Infectious Diseases (NIAID)
University of Alabama at Birmingham
Study Chair: William Dismukes University of Alabama at Birmingham
Office of Rare Diseases (ORD)
April 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP