Population Pharmacokinetics, Effectiveness and Safety of Cefuroxime in Neonates

NCT ID: NCT05388747

Last Updated: 2022-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-16

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Infectious Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Cefuroxime

Population pharmacokinetics, effectiveness, and safety of cefuroxime

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

0 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Central Hospital of Gynecology Obstetrics

OTHER

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Wei Zhao

Head of department of clinical pharmacy and pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tianjin Central Hospital of Gynecology Obstetrics

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Zhao, Ph.D

Role: CONTACT

86053188383308

Facility Contacts

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Xiuying Tian, bachelor

Role: primary

022-58287230

Other Identifiers

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2022-PPK-002

Identifier Type: -

Identifier Source: org_study_id

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