A Phase 3, Randomized, Double-Blind, Comparative Trial of Two Dosing Regimens of Micafungin (FK463) Versus Caspofungin for the Treatment of Esophageal Candidiasis
CompletadoFase 3ClinicalTrials.gov
ID: NCT00665639Tipo: INTERVENTIONALInicio: 1 de jun de 2004Fin estimado: 1 de dic de 2004
Traducción no disponible, mostrando original
Resumen
To determine the efficacy and safety of daily doses of IV micafungin versus IV caspofungin for the treatment of esophageal candidiasis
Elegibilidad
Edad mínima: 16 YearsSexo: ALL
Criterios de inclusión
Negative pregnancy test for female patients of childbearing potential
Esophageal candidiasis confirmed by endoscopy
Criterios de exclusión
Pregnant or nursing female patient
Evidence of liver disease
Another active opportunistic fungal infection and/or receiving acute systemic therapy for an opportunistic fungal infection
Concomitant esophagitis caused by herpes simplex virus or cytomegalovirus
Received an oral or topical antifungal agent within 48 hours or a systemic antifungal agent within 72 hours of first dose of study drug
Known to be non-responsive to therapy in any prior systemic antifungal clinical trail
History of anaphylaxis attributed to echinocandin class of antifungals
Intervenciones
drug
micafungin
IV
drug
caspofungin
IV
Ubicaciones
5 Sites
Buenos Aires, Argentina
Córdoba, Argentina
Neuquén, Argentina
Santa Fe, Argentina
Patrocinadores
PrincipalAstellas Pharma Inc
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