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Int J Antimicrob Agents. 2013 Aug;42(2):99-118. doi: 10.1016/j.ijantimicag.2013.05.001. Epub 2013 Jul 1.

New antibiotics for paediatric use: a review of a decade of regulatory trials submitted to the European Medicines Agency from 2000--why aren't we doing better?

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Division of Paediatrics, Regina Margherita Children's Hospital, University of Turin, Piazza Polonia 94, Turin, Italy.


New initiatives have been introduced in Europe and the USA to encourage more rapid development of antibiotics. The need to ensure these new antibiotics can be safely used in children, and especially neonates, is important owing to high antimicrobial resistance in these patient groups. This review aims to determine what lessons can be learnt from the recent regulatory processes to speed up access to new medicines for children, focusing on antibiotics licensed for adults by the EMA since 2000. For the 11 newly approved antibiotics, 31 clinical trials enrolling children in Europe were identified. However, many of these trials included both adults and children but did not provide a subset analysis for paediatrics, limiting the relevance of their findings. Some studies have been prematurely terminated and others are apparently active but are still not yet recruiting patients. Among paediatric-specific studies, 18 evaluate safety and efficacy of new compounds, 4 are pharmacokinetic studies, but only 2 focus on neonates. Nearly all studies with an agreed Paediatric Investigation Plan have just started or are not yet recruiting. For most antibiotics, despite adult phase 3 studies being completed, with specific concerns for particular drugs already noted, it will take another 3-5 years before adequate prescribing information becomes available for paediatricians. Evidence from this review suggests that we could do better. Lessons should be learnt from paediatric antiretroviral development, with neonatal and paediatric pharmacokinetic, clinical trial and pharmacovigilance drug development programmes being run directly in parallel with adult studies-not a decade behind.


Antibiotics; Clinical trial; European Medicines Agency; Neonates; Off-label use; Paediatrics

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