AN OPEN-LABEL, NON-COMPARATIVE STUDY OF FK463 IN THE TREATMENT OF CANDIDEMIA OR INVASIVE CANDIDIASIS

FUJISAWA HEALTH CARE INC,0 个研究点目标入组 0 人开始时间: 1999年8月24日最近更新: 2023年9月4日

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•a.Before to inclusion, an informed consent of the patient or legally authorized representative must be obtained. You will get a nod from underage patients able to understand.
•b.Patients can be of any sex. Female patients of childbearing age should have a negative pregnancy test.
•c.Patients should have candidemia or documented invasive candidiasis demonstrated by clinical signs and symptoms and confirmed by fungal culture or histological confirmation as specified in Appendix A of the protocol.
•De novo patients must have a positive culture obtained no more than 4 days before receiving the first dose of FK 463.
•Patients with therapeutic failure should have documented clinical and microbiological evidence of the continuation of their disease despite therapy with systemic antifungal agents
•It is possible that at the time of enrollment in the study, the results of the cultures are pending if the histology / cytology reveal Candida species.
•d.Patients should have adequate venous access to allow administration of FK463 and monitoring of safety variables.

•a.Patients who are pregnant or breast-feeding. Women of childbearing age should avoid pregnancy while receiving treatment with the study drug.
•b.Patients with any of the following abnormal test parameters hepatic:
•1.AST or ALT> 10 times over the limit of (ULN) normal.
•2.Total bilirubin > 5 times ULN
•3.Alkaline Phosphatase > 5 times ULN.
•c.Patients with a life expectancy considered to be less than 5 days.
•d.Patients with histone of allergies, hypersensitivity or any serious reaction to antifungal agents of the echinocandin class.
•e.De novo patients who have received a systemic antifungal agent for the treatment of this episode of candidemia or invasive candidiasis, for more than 48 hours prior to the first dose of FK463; or newborns with therapeutic failure who have received # 5 days of previous systemic antifungal therapy for the treatment of this episode of candidemia or invasive candidiasis.
•f.Patients who require treatment with topical or systemic antifungal agents for conditions other than candidemia or invasive candidiasis.
•g.Patients who have participated in this study previously.
•h.Patients with a concomitant medical condition, which in the opinion of the investigator and / or clinical monitor, participation may create an additional unacceptable risk to the patient.

发起方

FUJISAWA HEALTH CARE INC,