Phase 1 Completed N=20 Treatment

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

Sepsis

Source: ClinicalTrials.gov NCT00942149 ↗

Enrolled (actual)

Serious AEs

15.0%

Results posted

Dec 2012

Primary outcomePrimary: PK of Daptomycin — 262.4 mg*h/L

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY PK of Daptomycin	262.4	—
SECONDARY Adverse Events Will be Monitored.	—	—

Eligibility Criteria

Inclusion Criteria

> 48 hours and 1.0 mg/dL
Concomitant administration of tobramycin

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00942149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.