An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants

Summary

This is a safety and pharmacokinetic study of single-dose daptomycin in infants \> 48 hours and \< 120 days of age with suspected systemic infections. The investigators will enroll a total of 24 infants in 4 gestational age/postnatal age cohorts. Interim analyses will be performed after 3 infants are enrolled in each cohort. The investigators anticipate that 6 mg/kg of daptomycin will yield an AUC \<740 mch\*hr/mL.

Timeline

Start

2010-01

Primary completion

2011-12

Completion

2011-12

Drugs

Indications