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

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

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.

Inclusion Criteria:

1. > 48 hours and <120 days of age at the time of daptomycin administration
2. Sufficient venous access to permit administration of study medication
3. Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF) are obtained within 72 hours of study entry
4. Availability and willingness of the parent/legally authorized representative to provide written informed consent

Exclusion Criteria:

1. History of anaphylaxis attributed to daptomycin
2. Previous participation in the study
3. Exposure to daptomycin in the month prior to the study
4. Serum creatinine >1.0 mg/dL
5. Concomitant administration of tobramycin