Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

Overview

Cefuroxime is a time-dependent antibiotic that is used to treat bacterial infections. However, population pharmacokinetic,effectiveness and safety data for cefuroxime in neonates are lacking. The aim of this study was to assess the population pharmacokinetics, effectiveness, and safety of cefuroxime in neonates.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: July 1, 2025

Interventions

  • Drug: Cefuroxime
    • Population pharmacokinetics, effectiveness, and safety of cefuroxime

Clinical Trial Outcome Measures

Primary Measures

  • The peak plasma drug concentration of cefuroxime
    • Time Frame: at (5-10) minutes after intravenous administration
    • To detect the peak plasma drug concentration of cefuroxime after intravenous administration.
  • The random plasma drug concentration of cefuroxime
    • Time Frame: at (0.25-10) hours after intravenous administration.
    • To detect the random plasma drug concentration of cefuroxime after intravenous administration.
  • The trough plasma drug concentration of cefuroxime
    • Time Frame: at 1-2 hours before the next administration
    • To detect the trough plasma drug concentration of cefuroxime after intravenous administration.
  • The time of free drug concentration exceeding the minimal inhibitory concentration (fT>MIC)
    • Time Frame: Through study completion, an average of 3 days
    • PD target
  • Adverse events
    • Time Frame: Through study completion, an average of 15 days
    • Drug-related adverse events and serious adverse events

Participating in This Clinical Trial

Inclusion Criteria

  • Age: postnatal age ≤28 days; – Cefuroxime used as part of antimicrobial treatment; – Parental written consent. Exclusion Criteria:

  • Expected survival time less than the treatment cycle; – Receiving other systemic trial drug therapy; – Other factors that the researcher considers unsuitable for inclusion.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 28 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shandong University
  • Collaborator
    • Tianjin Central Hospital of Gynecology Obstetrics
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wei Zhao, Head of department of clinical pharmacy and pharmacology – Shandong University
  • Overall Contact(s)
    • Wei Zhao, Ph.D, 86053188383308, zhao4wei2@hotmail.com

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