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An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Doripenem in Infants (Term and Preterm), Less Than 12 Weeks Chronological Age Protocol DORI-PED-1003; P...

Mise à jour : Il y a 4 ans
Référence : EUCTR2009-014387-20

An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Doripenem in Infants (Term and Preterm), Less Than 12 Weeks Chronological Age Protocol DORI-PED-1003; Phase 1

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Extrait

The primary objective of this study is to evaluate the pharmacokinetics of doripenem after single-dose administration of doripenem to infants (term and preterm), <12 weeks chronological age (CA). Safety and tolerability will also be assessed.

Critère d'inclusion

  • Hospitalized but medically stable infants (term and preterm), <12 weeks CA, who have documented, presumed to have, or are at risk for bacterial infection(s) and are undergoing treatment with i.v. antibiotics

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