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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04961580
Other study ID # fdpicu-23
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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