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

Fudan University

Status: Enrolling

Conditions: Antibiotic Reaction; Sepsis

Treatments: Drug: Ceftazidime Avitbatan Sodium

Study type: Observational

Funder types: Other

Identifiers

NCT04961580

fdpicu-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 3 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Ceftazidime avitbatan sodiumt group

Description:

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.

Treatment:

Drug: Ceftazidime Avitbatan Sodium