Status:
COMPLETED
An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants
Lead Sponsor:
Duke University
Conditions:
Sepsis
Eligibility:
All Genders
48-120 years
Phase:
PHASE1
Brief 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 infan...
Eligibility Criteria
Inclusion
- \> 48 hours and \<120 days of age at the time of daptomycin administration
- Sufficient venous access to permit administration of study medication
- Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF) are obtained within 72 hours of study entry
- Availability and willingness of the parent/legally authorized representative to provide written informed consent
Exclusion
- History of anaphylaxis attributed to daptomycin
- Previous participation in the study
- Exposure to daptomycin in the month prior to the study
- Serum creatinine \>1.0 mg/dL
- Concomitant administration of tobramycin
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00942149
Start Date
January 1 2010
End Date
December 1 2011
Last Update
July 15 2013
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710