Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis

This study has been completed.

First Received: February 24, 2000 Last Updated: June 8, 2006 History of Changes

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator:	University of Alabama at Birmingham
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004938

Purpose

OBJECTIVE:

I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral sporotrichosis.

Condition	Intervention	Phase
Sporotrichosis	Drug: fluconazole	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Efficacy Study

Resource links provided by NLM:

Drug Information available for: Fluconazole

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	30
Study Start Date:	August 1996
Estimated Study Completion Date:	August 1996

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

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004938

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

University of Alabama at Birmingham

Investigators

Study Chair:

William Dismukes

University of Alabama at Birmingham

More Information

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.

Study ID Numbers:	199/11815, NIAID-MSG-11815
Study First Received:	February 24, 2000
Last Updated:	June 8, 2006
ClinicalTrials.gov Identifier:	NCT00004938 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

fungal infection
rare disease
sporotrichosis

Additional relevant MeSH terms:

Fluconazole
Anti-Infective Agents
Mycoses
Skin Diseases, Infectious
Skin Diseases
Therapeutic Uses

Antifungal Agents
Sporotrichosis
Infection
Pharmacologic Actions
Dermatomycoses

ClinicalTrials.gov processed this record on November 05, 2009