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Clinical trials for 2022-001837-35

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44366   clinical trials with a EudraCT protocol, of which   7389   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    1 result(s) found for: 2022-001837-35. Displaying page 1 of 1.
    EudraCT Number: 2022-001837-35 Sponsor Protocol Number: BPR-PIP-003 Start Date*: 2023-02-27
    Sponsor Name:Basilea Pharmaceutica International Ltd, Allschwil
    Full Title: A multicenter, open-label, single-arm, multiple-dose study to evaluate the safety, pharmacokinetics, and efficacy of ceftobiprole medocaril in term and pre-term neonates and infants up to 3 months ...
    Medical condition: Late-onset sepsis (LOS) in term and pre-term neonates and infants up to 3 months of age.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10053598 Late onset neonatal sepsis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed) LV (Prematurely Ended) SK (Completed) PL (Completed) Outside EU/EEA EE (Completed) BG (Completed) DE (Completed)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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