Fluconazole Versus Micafungin in Neonates With Candidiasis

Inclusion Criteria:

1. Neonates and infants between 24 up to 42 weeks gestational age AND with a post-natalage of 48 hours of life up to day of life (DOL) 120 at the time of cultureacquisition.

2. Requiring antifungal therapy according to medical decision by the attendingphysician for microbiologically documented or clinically suspected candida infectionindependently from the availability of any positive culture for Candida spp

3. Written informed consent from the parents or the legally authorized representativemust be obtained prior to entry.

4. Infant must have sufficient venous access to permit administration of studymedication and monitoring of safety variables.

5. And specifically for the French participants: infant shall be insured (HealthInsurance) - able to understand and accept the study constraints

Exclusion Criteria:

1. Infant exposed to fluconazole or micafungin prophylaxis prior to inclusion

2. Infant who has received more than 48 hours of systemic antifungal therapy (anyproduct) prior to the first dose of study drug for treatment of the current Candidainfection.

3. Infant with a concomitant medical condition, whose participation, in the opinion ofthe 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 anyechinocandin or fluconazole product

8. Infant with pre-existing hepatic or renal disease

9. Infants with baseline Candida spp. isolate resistant to fluconazole or micafunginaccording to "EUropean Committee on Antimicrobial Susceptibility Testing" and "Clinical and Laboratory Standards Institute" (EUCAST/CLSI) clinical breakpoints orwith an isolate for which treatment with an alternative antifungal agent isindicated, i.e. there is insufficient evidence that the species in question is agood target for therapy with either fluconazole or micafungin.