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

Recruiting

• Conditions: Sepsis; Antibiotic Reaction
• Interventions: Drug: Ceftazidime Avitbatan Sodium

• Registration Number: NCT04961580
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2021-07-05
• Study First Submitted QC: 2021-07-05
• Study First Posted: 2021-07-14
• Study Start: 2022-10-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ceftazidime avitbatan sodiumt group	Ceftazidime Avitbatan Sodium	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.

Primary Outcome Measures

Name	Time	Method
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter	Day 1-5	Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug

Secondary Outcome Measures

Name	Time	Method
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter	Day 1-5	Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug
Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter	Day 1-5	Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter	Day1-5	Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug
Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter	Day1-5	Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug

Trial Locations

Locations (1)

Children's hosptial of fudan university; 🇨🇳 Shanghai, Shanghai, China