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

Duke University

Status and phase: Completed; Phase 1

Conditions: Sepsis

Treatments: Drug: Daptomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00942149

dapto1 (Other Identifier)

Pro00019311

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 48 hours to 120 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Daptomycin cohort

Experimental group

Treatment:

Drug: Daptomycin