Pediatric Cefazolin PK Study

Summary

The primary objective of this study is: • To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis. The secondary objectives of this study are: * To compare the PK data in children aged 10 to 12 years (inclusive)receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system with modeling data for adolescents aged 13-17 years (inclusive) and historical data from adults receiving a single 2g dose of cefazolin. * To assess the safety of a single dose of cefazolin in children aged 10 to 12 years (inclusive) receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.

Timeline

Start

2013-03

Primary completion

2013-08

Completion

2013-09

Publications

• Background Nahata MC, Durrell DE, Ginn-Pease ME, King DR. Pharmacokinetics and tissue concentrations of cefazolin in pediatric patients undergoing gastrointestinal surgery. Eur J Drug Metab Pharmacokinet. 1991 Jan-Mar;16(1):49-52. doi: 10.1007/BF03189874.
• Schmitz ML, Blumer JL, Cetnarowski W, Rubino CM. Determination of appropriate weight-based cutoffs for empiric cefazolin dosing using data from a phase 1 pharmacokinetics and safety study of cefazolin administered for surgical prophylaxis in pediatric patients aged 10 to 12 years. Antimicrob Agents Chemother. 2015 Jul;59(7):4173-80. doi: 10.1128/AAC.00082-15. Epub 2015 May 4.

Drugs

Indications