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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Daptomycin

Criteria

Inclusion Criteria:

1. > 48 hours and <120 days of age at the time of daptomycin administration

2. Sufficient venous access to permit administration of study medication

3. Suspected to have systemic infection and appropriate cultures (blood +/- urine/CSF) are obtained within 72 hours of study entry

4. Availability and willingness of the parent/legally authorized representative to provide written informed consent

Exclusion Criteria:

1. History of anaphylaxis attributed to daptomycin

2. Previous participation in the study

3. Exposure to daptomycin in the month prior to the study

4. Serum creatinine >1.0 mg/dL

5. Concomitant administration of tobramycin