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

Completed · Phase 1

Conditions studied: Sepsis

In brief

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.

Key facts

Study ID

NCT00942149

Run by

Duke University

People needed

20

Starts

2010-01-01

Expected to finish

2011-12-01

Last updated by the study team

2013-07-15

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 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

You may not qualify if…

• 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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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