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

Phase 1

Completed

• Conditions: Sepsis
• Interventions: Drug: Daptomycin

• Registration Number: NCT00942149
• Lead Sponsor: Duke University

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-17
• Study First Posted: 2009-07-20
• Study Start: 2010-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2012-10-18
• Results First Submitted QC: 2012-11-15
• Results First Posted: 2012-12-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-07-01
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Daptomycin cohort	Daptomycin	-

Primary Outcome Measures

Name	Time	Method
PK of Daptomycin	24 hours	Area under the curve

Secondary Outcome Measures

Name	Time	Method
Adverse Events Will be Monitored.	7 days following last dose of study drug

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States