Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

Shandong University

Status: Enrolling

Conditions: Infectious Disease

Treatments: Drug: Cefuroxime

Study type: Observational

Funder types: Other

Identifiers

NCT05388747

2022-PPK-002

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No 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.