Fluconazole versus Micafungin in neonates with suspected or culture-proven Candidiasis: a randomized pharmacokinetic and safety study - Fluconazole versus Micafungin in neonates

Inserm0 个研究点目标入组 100 人开始时间: 2014年6月10日最近更新: 2016年1月25日

试验速览

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•1. Neonates and infants between 24 up to 42 weeks gestational age and with post-natal age of 48 hours of life up to day of life (DOL) 120 at the time of culture acquisition.
•2. Requiring antifungal therapy according to medical decision by the attending physician for microbiologically documented and clinically suspected candida infection independently from the availability of any positive culture for Candida spp.
•3. Written informed consent from the parents or the legally authorized representative must be obtained prior to entry.
•4. Infant must have sufficient venous access to permit administration of study medication and monitoring of safety variables.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Infant exposed to fluconazole or micafungin prophylaxis prior to inclusion
•2. Infant who has received more than 48hours of systemic antifungal therapy (any product) prior to the first dose of study drug for treatment of the current Candida infection
•3. Infant with a concomitant medical condition, whose participation, in the opinion of the investigator and / or medical advisor, may create an unacceptable additional risk
•4. Infant previously enrolled in this study
•5. Infant who is co-infected with a non-Candida fungal organism
•6. Neonates with isolated candiduria
•7. Infant with any history of a hypersensitivity or severe vasomotor reaction to any echinocandin or fluconazole product
•8. Infant with pre-existing hepatic or renal disease
•9. Infants with baseline Candida spp. Isolate resistant to fluconazole or micafungin according to EUCAST/CLSI clinical breakpoints (see section 5.2.2 for interpretative MIC criteria) or with an isolate for which treatment with an alternative antifungal agent is indicated, i.e. there is insufficient evidence that the species in question is a good target for therapy with either fluconazole or micafungin.

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