Evaluation of PK, Safety & Tolerability of Doripenem in Infants <12wks

• Research type

  Research Study

• Full title

  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.

• IRAS ID

  28171

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2009-014387-20

• Research summary

  Doripenem is a new carbapenem antibiotic approved in the United States (U.S.) and the European Union (EU) for the treatment of specific types of complicated infections in adults. The aim of this study is to evaluate the pharmacokinetics of Doripenem (the way the drug is handled by the body) after single-dose administration of Doripenem to infants (term and preterm), < 12 weeks chronological age (CA). Safety and tolerability will also be assessed. The study will enrol 48 subjects who have documented, presumed to have, or are at risk for bacterial infection(s) and are undergoing treatment with intravenous antibiotics (dripped through a vein), in a number of hospitals, internationally. Doripenem is not being used in this study to treat infection and it will not replace the subjects?? prescribed antibiotic(s). Of the 48 subjects enrolled, 32 will be neonatal male and female subjects (birth to less than 4 weeks CA) and 16 infant male and female subjects (4 weeks to less than 12 weeks CA). Study assessments will be performed over a period of up to 9 days; including a pre-treatment screening phase, a 1-day open-label treatment phase (Day 1) during which the pharmacokinetics of Doripenem will be assessed, a post treatment phase (end-of-study procedures on Day 1), and a follow-up assessment (Day 7).

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/110

• Date of REC Opinion

  1 Oct 2009

• REC opinion

  Further Information Favourable Opinion