MedTrace Logo

Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects

NCT03231228 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2020-07-13

Study results available
· View outcomes & findings →

Summary

This is a Phase 4, open-label, single-dose, parallel-group, multicenter, safety study of cefazolin (1 g or 2 g) in pediatric subjects between 10 and 17 years of age (inclusive) scheduled for surgery.

Conditions

  • Postoperative Infection

Interventions

DRUG

Cefazolin 1 g Infusion

1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to \<60 kg

DRUG

Cefazolin 2 g Infusion

2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg

Sponsors & Collaborators

  • B. Braun Medical Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2019-07-31
Completion
2019-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03231228 on ClinicalTrials.gov