The TINN study in candidiasis infections among newborns and neonates will take place in about 15 centres across France, Belgium, The Netherlands and Spain. The study is set-up within a European project funded by the European Commission, the Health Co-operation Work Program of the 7th Framework Program. The Project is coordinated by Prof. Evelyne Jacqz-Aigrain (Hôpital Robert Debré, Paris, France) with the academic sponsor INSERM (Institut National de la Santé et de la Recherche Médicale). The CIEC trough the ECRIN network will manage the sites located in Belgium and The Netherlands.
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, fluconazole prophylaxis is now recommended in NICUs with a high incidence in fungal infections.
As candida infection is difficult to prove and requires an urgent treatment, in particular to avoid 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.
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Related to Micafungin, the available data support the idea that only dosages that are greater than what currently recommended in infants (that is, 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.
Therefore, this randomized phase 2-3 study is designed to determine whether micafungin is as efficacious as the current standard of fluconazole, as well as, compare the safety of the 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.
Detailed information about this study are available here: www.luxclin.lu/Studies/Details/?c=STP2700CGP
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