Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis - Tabular View

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

June 8, 2006

Start Date ^ICMJE

August 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004938 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis

Official Title ^ICMJE

Brief Summary

OBJECTIVE:

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

Detailed Description

PROTOCOL OUTLINE:

Patients are treated with daily oral fluconazole for up to 24 months. Follow-up continues for at least 1 year.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Efficacy Study

Condition ^ICMJE

Sporotrichosis

Intervention ^ICMJE

Drug: fluconazole

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 1996

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Both

Ages

12 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004938

Responsible Party

Study ID Numbers ^ICMJE

199/11815, NIAID-MSG-11815

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

University of Alabama at Birmingham

Investigators ^ICMJE

Study Chair:

William Dismukes

University of Alabama at Birmingham

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

April 2000

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