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Pediatric Cefazolin PK Study

NCT01904357 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-07-21

No results posted yet for this study

Summary

The primary objective of this study is:

• To examine the pharmacokinetics (PK) of cefazolin in children aged 10 to 12 years (inclusive) receiving weight-dependent 1gram (g) or 2g of cefazolin intravenous (IV) delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.

The secondary objectives of this study are:

* To compare the PK data in children aged 10 to 12 years (inclusive)receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system with modeling data for adolescents aged 13-17 years (inclusive) and historical data from adults receiving a single 2g dose of cefazolin.
* To assess the safety of a single dose of cefazolin in children aged 10 to 12 years (inclusive) receiving 1g or 2g of cefazolin IV delivered over 30 minutes via the DUPLEX® drug delivery system for surgical prophylaxis.

Conditions

Interventions

DRUG

Cefazolin 1 GM Injection

Subjects weighing ≥25 kg and \< 50 kg will receive the 1g dose.

DRUG

Cefazolin 2 GM Injection

Subjects weighing ≥50 kg to ≤85 kg will receive the 2g dose.

Sponsors & Collaborators

  • B. Braun Medical Inc.

    lead INDUSTRY

Principal Investigators

  • Michael L Schmitz, MD · Arkansas Children's Hospital Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-08-31
Completion
2013-09-30

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01904357 on ClinicalTrials.gov