A Phase 2/3 interventional study of Fluconazole and Micafungin in Candidiasis, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Completed at 5 sites in 5 countries. Open to participants aged 24 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Phase 2/3, Interventional, and Treatment
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.
The epidemiology of candidiasis is rapidly changing; recent estimates are that nearly 50% of Candida bloodstream isolates are non-albicans Candida species requiring the use of treatments active against them.
Because of the high risk associated with candida infection in premature babies and fluconazole prophylaxis is now recommended in Neonatal Intensive Care Units (NICUs) with a high incidence in fungal infections. As candida infection is difficult to prove and requires an urgent treatment, in particular to avoid central nervous system (CNS) infection, treatment is often started in high risk patients when the infection is only suspected, i.e. on clinical arguments without waiting for positive cultures (10% of cases).
Fluconazole has not been approved for use in the treatment of neonatal candidiasis. In contrast, the efficacy of echinocandins for the treatment of invasive candidiasis has been suggested by pre-clinical and clinical studies.
Related to Micafungin, the available data suggest that only dosages that are greater than what currently recommended in infants (2 to 4 mg/kg/day) may ensure adequate coverage of the CNS, given that ability of low dosages of micafungin to penetrate the cerebrospinal compartment and to diffuse in the cerebrospinal fluid is deemed suboptimal.
The doses that will be administered are higher that currently used in order to optimize efficacy, and the concept of a loading dose that will be used for both drugs in this project, is present in antifungal treatment strategies for adults, but it has never been applied to infants and preterm neonates.
132 studies on the registry are indexed under Candidiasis; 9 are open to participants now.
This study's planned enrollment of 100 is close to the median of 91 across 86 interventional studies indexed under Candidiasis.
Browse Candidiasis studies →Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 378 studies on the registry; 81 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fluconazole 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.
Drug: Fluconazole
Mycamine 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.
Drug: Micafungin
Also known as: Antifungal
Also known as: Antifungal
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.
Time frame: One year
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fluconazole · Micafungin
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