Fluconazole Versus Micafungin in Neonates With Candidiasis
TINN
2 other identifiers
interventional
100
5 countries
5
Brief Summary
This study is designed to determine whether micafungin is as efficacious as the current standard of fluconazole, to compare the safety of the two drugs in the treatment of proven neonatal candidiasis. It is also designed to further elucidate the pharmacokinetics of the two products in the growing and developing neonate and premature infant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2014
Shorter than P25 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2014
CompletedFirst Posted
Study publicly available on registry
May 23, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedSeptember 4, 2025
January 1, 2025
1.1 years
May 15, 2014
August 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area Under the Concentration / Minimal Inhibitory Concentration ratio (AUC/MIC ratio)
AUC/MIC ratio in the two treated groups (both fluconazole and micafungin) is used as primary outcome. The theoretical "Minimum Inhibitory Concentration required to inhibit the growth of 90% of organisms" (MIC90s) against the common pathogens responsible for the infection to be treated will be used by opposition with the "real MIC90" of the agent really involved that is rarely isolated.
One year
Study Arms (2)
Fluconazole
EXPERIMENTALFluconazole Kabi, Fresenius 2mg/ml Fluconazole will be administered at a loading dose of 25 mg/kg on the first day and followed by a maintenance dose of 12 mg/kg or 20 mg/kg once daily, depending of corrected gestational age (GA) at the beginning of treatment: * 12 mg/kg/day for neonates corrected GA (GA + postnatal age) \< 30 weeks * 20 mg/kg/day for neonates corrected GA (GA + postnatal age) ≥ 30 weeks The infusion will last two hours.
Micafungin
EXPERIMENTALMycamine 50mg - 10 mg/mL of micafungin Micafungin will be administered as a loading dose of 15 mg/kg on the first day of treatment and followed by a maintenance dose of 10 mg/kg once daily. The infusion will last two hours.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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
- Written informed consent from the parents or the legally authorized representative must be obtained prior to entry.
- Infant must have sufficient venous access to permit administration of study medication and monitoring of safety variables.
- And specifically for the French participants: infant shall be insured (Health Insurance) - able to understand and accept the study constraints
You may not qualify if:
- 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.
- Infant with a concomitant medical condition, whose participation, in the opinion of the Investigator and/or medical advisor, may create an unacceptable additional risk.
- Infant previously enrolled in this study.
- Infant who is co-infected with a non-Candida fungal organism.
- Neonates with isolated candiduria
- Infant with any history of a hypersensitivity or severe vasomotor reaction to any echinocandin or fluconazole product
- Infant with pre-existing hepatic or renal disease
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Antwerp, Rocourt, Liège, Louvain, Namur, Belgium
Unknown Facility
Paris, Lyon, Saint-Pierre de La Réunion, France
Unknown Facility
Roma, Torino, Catania, Foggia, Reggio Emilia, Italy
Unknown Facility
Rotterdam, Amsterdam, Utrecht, Isala, Netherlands
Unknown Facility
Malaga, Salamanca, Spain
Related Publications (1)
Leroux S, Jacqz-Aigrain E, Elie V, Legrand F, Barin-Le Guellec C, Aurich B, Biran V, Dusang B, Goudjil S, Coopman S, Garcia Sanchez R, Zhao W, Manzoni P; FP7 TINN (Treat Infections in NeoNates) consortium. Pharmacokinetics and safety of fluconazole and micafungin in neonates with systemic candidiasis: a randomized, open-label clinical trial. Br J Clin Pharmacol. 2018 Sep;84(9):1989-1999. doi: 10.1111/bcp.13628. Epub 2018 Jun 21.
PMID: 29744900BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2014
First Posted
May 23, 2014
Study Start
October 1, 2014
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
September 4, 2025
Record last verified: 2025-01