Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05388747

Enrollment

100

Registered

2022-05-24

Start date

2022-05-16

Completion date

2025-12-01

Last updated

2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious Disease

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.

Interventions

DRUGCefuroxime

Population pharmacokinetics, effectiveness, and safety of cefuroxime

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Days to 28 Days

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactWei Zhao, Ph.D

zhao4wei2@hotmail.com86053188383308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026