Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis (NCT00004808) | Clinical Trial Compass
CompletedPhase 2
Phase II Pilot Study of Fluconazole for Histoplasmosis, Blastomycosis, and Sporotrichosis
78 participantsStarted 1991-09
Plain-language summary
OBJECTIVES: I. Identify a preferred oral fluconazole dose regimen for patients with non-acute histoplasmosis or blastomycosis, or ulcerocutaneous or deep sporotrichosis.
II. Study the safety and efficacy of fluconazole in these patients.
Who can participate
Age range12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
* Clinical, radiographic, nuclear medicine, or similar study findings compatible with active infection with any of the following: Histoplasma capsulatum Blastomyces dermatiditis Sporothrix schenckii
* At least 1 positive culture within 8 weeks prior to entry Diagnostic histopathology fulfills requirement if confirmed by second independent reviewer
* Sporotrichosis, i.e.: Ulcerocutaneous disease limited to local or regional skin and lymphatics OR Deep infection of tissue or sites other than locoregional skin/lymphatics
* Histoplasmosis and blastomycosis with acute pulmonary infection as sole site of disease eligible only if progressive, i.e.: Clinically or radiographically apparent new lesions or continued increase in old lesions for more than 20 days after acute illness onset Positive culture or histopathology at least 20 days after illness onset
* Relapsed disease eligible, as follows: Clinical evidence of active disease Positive culture within 8 weeks prior to entry Histopathologic evidence alone not acceptable for entry No more than 3 days of systemic amphotericin B or ketoconazole since positive culture
* Infection site present at study entry, i.e., no prior surgical removal
* No active meningeal or central nervous system infection Diagnostic tests required if symptomatic
* No immediately life-threatening infection
--Patient Characteristics--
* Life expectancy: At least 1 week
* Hepatic: AST and ALT no greater than …
Trial details
NCT IDNCT00004808
SponsorNational Center for Research Resources (NCRR)