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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04961580
• Other study ID #: fdpicu-23
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: Children's Hospital of Fudan University
• Contact: Yixue Wang, Doctor
• Phone: 8613524669352
• Email: yixuewang08[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Reaction
• Infections
• Sepsis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Children's hosptial of fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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