Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

NCT05388747 | Unknown FDA Drug

• 1 other identifier: 2022-PPK-002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Disease

Outcome Measures

Primary Outcomes (5)

• 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

• 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.

• 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

• The time of free drug concentration exceeding the minimal inhibitory concentration (fT>MIC)

  PD target

  Through study completion, an average of 3 days

• Adverse events

  Drug-related adverse events and serious adverse events

  Through study completion, an average of 15 days

Interventions

Cefuroxime DRUG

Population pharmacokinetics, effectiveness, and safety of cefuroxime

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

neonatal patients with infections

You may qualify if:

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

You may not qualify if:

• Expected survival time less than the treatment cycle;
• Receiving other systemic trial drug therapy;

Sponsors & Collaborators

• Shandong University: lead
• Tianjin Central Hospital of Gynecology Obstetrics: collaborator

Study Sites (1)

Tianjin Central Hospital of Gynecology Obstetrics

Tianjin, Tianjin Municipality, 30000, China

RECRUITING

MeSH Terms

Conditions

Communicable Diseases

Interventions

Cefuroxime

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Wei Zhao, Ph.D

CONTACT

86053188383308; zhao4wei2@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department of clinical pharmacy and pharmacology

Study Record Dates

• First Submitted: May 22, 2022
• First Posted: May 24, 2022
• Study Start: May 16, 2022
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

CN (1)