Phase 1
N=20
An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants
Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT00942149 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Dec 2012
Primary outcome: Primary: PK of Daptomycin — 262.4 mg*h/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Daptomycin (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PK of Daptomycin |
262.4 | — |
| SECONDARY Adverse Events Will be Monitored. |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- > 48 hours and 1.0 mg/dL
- Concomitant administration of tobramycin
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.