An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
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.