Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT02145832
Eligibility Criteria:
Inclusion Criteria:
1. Neonates and infants between 24 up to 42 weeks gestational age AND with a 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 or 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.
5. And specifically for the French participants: infant shall be insured (Health Insurance) - 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 (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 "EUropean Committee on Antimicrobial Susceptibility Testing" and "Clinical and Laboratory Standards Institute" (EUCAST/CLSI) clinical breakpoints 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Weeks
Maximum Age:
42 Weeks
Study:
NCT02145832
Study Brief:
Protocol Section:
NCT02145832