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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pharmacokinetics and Pharmacodynamics of Ceftazidime Avitbatan Sodium in Children With Severe Infection

Conditions
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Sepsis, Antibiotic Reaction

Intervention / Treatment
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* Drug: Ceftazidime Avitbatan Sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ceftazidime avitbatan sodiumt group<br>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. | Drug: Ceftazidime Avitbatan Sodium<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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