Open Label, Treatment Protocol for the Safety and Efficacy of Posaconazole (SCH 56592) in the Treatment of Invasive Fungal Infections

SCHERING PLOUGH RESEARCH INSTITUTE,0 个研究点目标入组 0 人开始时间: 1999年10月4日最近更新: 2023年9月4日

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•Adults (age> 18 years) of both sexes and of any race, or children (age> 13 years) of both sexes and of any race.
•Subjects must have proven or probable invasive fungal infection.
•Subjects must have an invasive fungal infection resistant or refractory to standard antifungal therapies (Appendix B)
•Informed written consent of the patient or legally authorized representative obtained before entering the study.
•Patients who can take the study medication orally.
•Subjects must be willing to respect the dose schedules, visits and mandatory procedures.
•Women of childbearing age, including those taking oral contraceptives, should use a reliable barrier method of contraception during the study.
•Women of childbearing age must have a serum or negative urine pregnancy test within 72 hours prior to the start of! study drug treatment.

•Pregnant or breastfeeding women.
•History of hypersensitivity or susceptibility to antlfungal azoles.
•Concurrent progressive neurological disease (except if it is a consequence of invasive fungal infection).
•Use of medications that interact with azoles and cause life-threatening effects: terfenadine, cisapride, ebastine, upon entering the study or within 24 hours prior to therapy, or astemizole upon entering the study or within the 10 days prior to admission.
•Use of medications that decrease the serum concentration / efficacy of antlfungal azoles: rifampicin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid, upon entering the study or within 3 weeks prior to admission.
•Subjects receiving vinca or anthracycline alkaloids upon entering the study or during treatment with SCH 56592.
•Subjects with an ECG with prolongation of the QTc interval> 20% higher than normal.
•Any condition that requires the use of prohibited medications, (see Section 3.4.3.2.)
•Early or concurrent use of systemic antifungal agents (intravenously or orally) during the study period.
•Liver function tests: alanine aminotransferase (ALT) and aspartate aminotransferase (AST)> 10 times the upper limit of normal.
•Previous participation in this study.
•Subjects that, in the opinion of the Researcher, present clinical conditions or laboratory tests that may hinder the evaluation of the safety and efficacy of SCH 56592.

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