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Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis



Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis

For Condition: Sporotrichosis
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , University of Alabama
Synopsis: OBJECTIVE: I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral sporotrichosis.
Details: PROTOCOL OUTLINE: Patients are treated with daily oral fluconazole for up to 24 months. Follow-up continues for at least 1 year.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Efficacy Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 30

Location and Contact Information:

Overall Study Official:
WilliamDismukes,  Study Chair,  University of Alabama


Additional Information:
Study ID Numbers:
  199/11815;  NIAID-MSG-11815
Study Start Date: August 1996
Record last reviewed: April 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004938

Other Sporotrichosis Studies:
1. Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis

2. Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis

3. Phase I/II Study of Itraconazole for Blastomycosis, Histoplasmosis, and Sporotrichosis

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