Ciprofloxacin and Fluconazole are two anti-infectious drugs included in the EMEA priority list of the therapeutic areas that need specific drug evaluation in preterm and term neonates. These two drugs are prescribed off-label to treat neonatal infections that are life-threatening situations, making neonates seriously ill or even kill them.

To improve the situation, the TINN project will conduct two clinical trials to evaluate the efficacy and safety of ciprofloxacine and fluconazole, administered as formulations adapted to preterm and term neonates, in order to apply for a Peadiatric Use Marketing Authorization (PUMA).

Ciprofloxacin is an antibiotic drug administered to treat neonates with sepsis caused by multiple resistant organisms, against which only ciprofloxacin is effective.

Fluconazole is an antifungal drug administered to prevent and/or treat neonates with invasive candidiasis.

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