Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

Infectious Disease Clinical Trial

Official title:

Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05388747
• Other study ID #: 2022-PPK-002
• Status: Recruiting
• Start date: May 16, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2022
• Source: Shandong University
• Contact: Wei Zhao, Ph.D
• Phone: 86053188383308
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Disease

Intervention

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

Locations

Country	Name	City	State
China	Tianjin Central Hospital of Gynecology Obstetrics	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Shandong University	Tianjin Central Hospital of Gynecology Obstetrics

Country where clinical trial is conducted

China, 

Outcome

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