Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

Recruiting

• Conditions: Infectious Disease

• Registration Number: NCT05388747
• Lead Sponsor: Shandong University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-05-16
• Study First Submitted: 2022-05-22
• Study First Submitted QC: 2022-05-22
• Last Update Submitted: 2022-05-22
• Study First Posted: 2022-05-24
• Last Update Posted: 2022-05-24
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The peak plasma drug concentration of cefuroxime	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	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	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)	Through study completion, an average of 3 days	PD target
Adverse events	Through study completion, an average of 15 days	Drug-related adverse events and serious adverse events

Trial Locations

Locations (1)

Tianjin Central Hospital of Gynecology Obstetrics; 🇨🇳 Tianjin, Tianjin, China