At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
Daptomycindrug
Likely dose
Daptomycin 6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants
In Brief
A Phase 1 clinical trial evaluating Daptomycin for Sepsis. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2009
Enrollment StartJan 2010
Primary CompletionDec 2011
TodayJul 2026
First PostedJul 20, 2009
Enrollment StartJan 1, 2010
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.9 years ago
Interventions
Daptomycindrug
single dose of 6 mg/kg of daptomycin