Fluconazole and micafungin in neonates

Conditions: eonates with suspected or culture-proven candidiasis
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2012-001916-41-BE

Lead Sponsor: Inserm

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

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 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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the pharmacokinetics of fluconazole and micafungin both administered after randomization in neonates with suspected or culture-proven Candidiasis in order to validate their optimal dosage.<br>To compare the time to reach the target drug exposure area under the concentration-time curve from 0 to 24 h (AUC0–24) for candidiasis by the two randomly administered drugs. ;Secondary Objective: To evaluate the tolerability of fluconazole and micafungin in neonates with suspected or culture-proven Candidiasis<br><br>To describe short-term safety<br><br>To describe short term outcome of treated episodes<br><br>;Primary end point(s): PK/PD integration of pharmacokinetics and pharmacodynamics;Timepoint(s) of evaluation of this end point: Time to reach the AUC breakpoint ant the ratio of AUC/MIC90s in the two treated groups

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Definition of efficacy evaluation criteria (primary and secondary) measurement techniques;Timepoint(s) of evaluation of this end point: The procedures or evaluations will be performed on the days of PK study<br>