Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

May 22, 2022 updated by: Wei Zhao, Shandong University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 30000
        • Recruiting
        • Tianjin Central Hospital of Gynecology obstetrics
        • Principal Investigator:
          • Xiuying Tian, bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

neonatal patients with infections

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The peak plasma drug concentration of cefuroxime
Time Frame: at (5-10) minutes after intravenous administration
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
Time Frame: at (0.25-10) hours after intravenous administration.
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
Time Frame: at 1-2 hours before the next administration
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)
Time Frame: Through study completion, an average of 3 days
PD target
Through study completion, an average of 3 days
Adverse events
Time Frame: Through study completion, an average of 15 days
Drug-related adverse events and serious adverse events
Through study completion, an average of 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Collaborators

Tianjin Central Hospital of Gynecology Obstetrics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 16, 2022

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

May 22, 2022

First Submitted That Met QC Criteria

May 22, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 22, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-PPK-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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