PFIZER R 0437:STUDY OF FLUCONAZOLE + AMPHOTERICIN B IN TREATMENT OF C

$11,180M01FY2000RRNIH

Tulane University Of Louisiana, New Orleans LA

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Abstract

This is a randomized, double-blind study of the treatment of candidemia and its consequences in non-neutropenic patients, comparing the efficacy, tolerance, and safety of fluconazole to that of fluconazole plus amphotericin B. Fluconazole is a novel orally effective triazole antifungal agent. It has been found to be effective in models of fungal infection in both normal and immunocompromised animals, including experimental cryptococcosis of mice and rabbits and murine candidiasis and histoplasmosis. In addition, human studies involving AIDS patients with CNS cryptococcus and non-neutropenic patients with systemic candidiasis also demonstrate clinical efficacy of fluconazole. In animal studies, fluconazole usually has not eradicated the fungus from all tissues, as can be accomplished with amphotericin B, but it has significantly prolonged life and decreased tissue burden of pathogenic fungi. In this respect, fluconazole resembles imidazoles and other triazoles.

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