The primary purpose of this study is to evaluate the pharmacokinetic profile of micafungin administered to neonates suffering from systemic candidiasis. This study will also evaluate the proportion of success and of failure of the therapy with micafungin among treated neonates and will identify a conversion factor to relate plasma levels of micafungin into capillary and venous blood measured through blood samples from the heel and from a peripheral vein, collected simultaneously. Safety of micafungin in neonates will also be assessed.
Age range
1 Day – 180 Days
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Concentration of Micafungin in Blood
Timeframe: Predose and after 1, 3, and 8 hours post-dose on one of treatment days from Day 3 to Day 10
Concentration of Micafungin in Cerebral Spinal Fluid (CSF)
Timeframe: Predose and after 1, 3, and 8 hours post-dose on one of treatment days from Day 3 to Day 10