An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants
| Status: | Archived |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | January 2010 |
| End Date: | September 2010 |
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.
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