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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•Prior to inclusion, informed consent must be obtained from the patient or the legally authorized representative. An agreement will be obtained from the underage patients able to understand.
•Patients can be of any sex. Female patients of childbearing age must have a negative pregnancy test.
•Patients must have documented candidemia or invasive candidiasis demonstrated by clinical signs and symptoms and confirmed by fungal culture or histological confirmation as specified in Appendix A of the protocol.
•Patients must have adequate venous access to allow the administration of FK463 and the monitoring of safety variables.

•Pregnant or breastfeeding patients. Women of childbearing age should avoid pregnancy while receiving treatment with the drug being studied.
•Patients with any of the following abnormal liver test parameters: 1. AS r or ALT> 10 times above the normal (ULN) limit 2. Total bilirubin> 5 times ULN 3. Alkaline phosphatase> 5 times ULN.
•Patients with a life expectancy considered less than 5 days.
•Patients with a history of allergies, hypersensitivity or any serious reaction to antifungals of the echinocandin class.
•De novo patients who have received a systemic antifungal agent for the treatment of this episode of invasive candidemia or candidiasis, for more than 48 hours prior to the first dose of FK463; or patients with therapeutic failure who have received U 5 days of prior systemic antifungal therapy for the treatment of this episode of candidemia or invasive candidiasis.
•Patients who require treatment with topical or systemic antifungal agents for conditions other than candidemia or invasive candidiasis.
•Patients who have participated in this study before.
•Patients with a concomitant medical condition, which in the opinion of the investigator and / or clinical monitor, participation may create an additional risk unacceptable to the patient.

发起方

FUJISAWA HEALTH CARE INC,