Conditions: Sepsis
Keywords: Infants Daptomycin
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Daptomycin
Intervention descriptions: intervention 1: single dose of 6 mg/kg of daptomycin

Protocol document: