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

NCT00942149 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-07-15

Study results available
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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.

Conditions

Interventions

DRUG

Daptomycin

single dose of 6 mg/kg of daptomycin

Sponsors & Collaborators

Principal Investigators

  • P Brian Smith, MD MHS · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
48 Hours
Max Age
120 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00942149 on ClinicalTrials.gov