A Study of Doripenem in Infants Less Than 12 Weeks of Age

Summary

The purpose of this study is to measure drug levels of doripenem in blood samples collected before and after administration of doripenem to infants less than 12 weeks of age who are hospitalized and documented, presumed to have, or are at risk for bacterial infection (s) and are undergoing treatment with intravenous (i.v.) antibiotics. Safety and tolerability will also be assessed.

Timeline

Start

2009-10

Primary completion

2012-04

Completion

2012-04

Publications

• Cirillo I, Vaccaro N, Castaneda-Ruiz B, Redman R, Cossey V, Bradley JS, Allegaert K. Open-Label Study To Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Doripenem in Infants Less than 12 Weeks in Chronological Age. Antimicrob Agents Chemother. 2015 Aug;59(8):4742-9. doi: 10.1128/AAC.00485-15. Epub 2015 May 26.

Drugs

Indications