Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis

This study has been completed.
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004938
First received: February 24, 2000
Last updated: June 8, 2006
Last verified: April 2000

February 24, 2000
June 8, 2006
August 1996
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00004938 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis
Not Provided

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
Endpoint Classification: Efficacy Study
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
Not Provided

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

Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00004938
199/11815, NIAID-MSG-11815
Not Provided
Not Provided
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