Clinical trial NCT04961580: PK/PD of Ceftazidime Avitbatan Sodium in Children With Severe Infection
Official title: Pharmacokinetics and Pharmacodynamics of Ceftazidime Avitbatan Sodium in Children With Severe Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Antibiotic Reaction
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children receiving cefatadine and averbactam sodium in pediatric intensive care unit including but not limited to children with liver insufficiency, hypoproteinemia, ECMO treatment, CRRT treatment or sepsis.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
timeFrame: Day 1-5
Secondary outcomes:
measure: Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter
timeFrame: Day 1-5
measure: AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter
timeFrame: Day 1-5
measure: AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter
timeFrame: Day1-5
measure: Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter
timeFrame: Day1-5
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hosptial of fudan university
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Guoping Lu, doctor
role: PRINCIPAL_INVESTIGATOR
References: