CompletedPhase 3

Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P02095)

Started 2001-04

Plain-language summary

This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections: A. which are refractory or resistant to standard antifungal therapies; B. for which there are currently no effective therapies; C. with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D. with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.

Who can participate

Age range13 Years – 65 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.

Inclusion Criteria: * Proven or probable invasive fungal infections according to EORTC/MSG criteria. * IFI are documented to be refractory to standard antifungal therapy OR intolerant to standard therapy. * Able to take oral medication or take medication via enteral feeding tube. Exclusion Criteria: * History of serious or severe hypersensitivity or idiosyncratic reactions to azole antifungals. * Concurrent progressive neurological disease (except if due to invasive fungal infection) * Use of medications that are known to interact with azoles and that may lead to life-threatening side effects: terfenadine, cisapride, ebastine at entry or within 24 hours prior to therapy, or astemizole at entry or within 10 days prior to entry.concentration/efficacy of azole antifungals: rifampin, carbamazepine. * Females pregnant or nursing.

Trial details

NCT IDNCT00034632

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-03

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