Back to resultsPhase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis
Primary Purpose
Sporotrichosis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
fluconazole
Sponsored by
About this trial
This is an interventional treatment trial for Sporotrichosis focused on measuring fungal infection, rare disease, sporotrichosis
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004938
First Posted
February 24, 2000
Last Updated
June 8, 2006
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT00004938
Brief Title
Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2000
Overall Recruitment Status
Completed
Study Start Date
August 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 1996 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
University of Alabama at Birmingham
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sporotrichosis
Keywords
fungal infection, rare disease, sporotrichosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
fluconazole
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Dismukes
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
8824965
Citation
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. doi: 10.1093/clinids/22.1.46.
Results Reference
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Learn more about this trial
Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis
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