PK/PD of Ceftazidime Avitbatan Sodium in Children With Severe Infection

NCT ID: NCT04961580

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2026-12-31

Brief Summary

Ceftazidime avitbatan sodium is a broad-spectrum antibiotic with an antimicrobial spectrum covering resistant gram-negative bacteria. Its use in pediatric intensive care for severe infections is not unusual. Pathophysiological changes in severe sepsis can lead to significant changes in pharmacokinetics and pharmacodynamics during continuous renal replacement therapy.This research aims to study change of pharmacokinetic and pharmacodynamic in severe infection children with extracorporeal life support, thus improve the treatment of severe sepsis and sepsis shock.

Detailed Description

This study is an observational clinical study. Subjects were recruited from children with severe infection receiving ceftazidime avitbatan sodium under routine clinical diagnosis and treatment routine. There is no control, no double-blind randomized design, and the normal treatment schedule of patients was not interfered with, and the disease risk of patients was not increased.All subjects had received at least 5 doses of ceftazidime avitbatan Sodium before enrollment.

Blood sampling time points of ceftazidime avitbatan sodium are listed as follow:

Before administration (0 min); 5,30 min,1 h,2 h,4 h and 8 h after administration, if blood purification is received, one blood sample will be collected before and after the filter at the same time point.

The concentration of ceftazidime avitbatan sodium in whole blood will be analyzed at Huashan Hospital of Fudan University.

Conditions

Sepsis; Antibiotic Reaction

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Ceftazidime avitbatan sodiumt group

Children treated with ceftazidime avitbatan sodium in the pediatric intensive care unit will be enrolled in this group. Blood sample will be retained at various time intervals for pharmacokinetics.

Ceftazidime Avitbatan Sodium

Intervention Type: DRUG

For 6-18 years children, 62.5 mg/kg/once，q8h ; 3-6 months of age 50 mg/kg/ once,q8h, intravenous administration for 2 hours, daily dose is not more than 2.5g, children will be administrated at least five times.

Interventions

Ceftazidime Avitbatan Sodium

For 6-18 years children, 62.5 mg/kg/once，q8h ; 3-6 months of age 50 mg/kg/ once,q8h, intravenous administration for 2 hours, daily dose is not more than 2.5g, children will be administrated at least five times.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Children who are admitted in the pediatric intensive care unit receiving ceftazidime avitbatan sodium

Exclusion Criteria

• No Informed Consent signed
• Participate in other clinical trials

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guoping Lu, doctor

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

Children's hosptial of fudan university

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yixue Wang, Doctor

Role: CONTACT

yixuewang08@aliyun.com

8613524669352

Facility Contacts

LU guoping, dotor

Role: primary

13788904150@163.com

18017590817

Other Identifiers

fdpicu-23

Identifier Type: -

Identifier Source: org_study_id