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NCT Number: NCT04961580

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

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.

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Key information

Conditions

Sepsis Antibiotic Reaction Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

3 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's hosptial of fudan university

Shanghai, Shanghai Municipality, 201102, China

Location status: Recruiting

Location contact

LU guoping, dotor

CONTACT

[email protected]

18017590817

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ceftazidime Avitbatan Sodium

Drug

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.

Primary outcomes

  1. Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter

    Time frame: Day 1-5

    Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug

Secondary outcomes

  1. Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter

    Time frame: Day 1-5

    Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.

  2. AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter

    Time frame: Day 1-5

    Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug

  3. AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter

    Time frame: Day1-5

    Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug

  4. Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter

    Time frame: Day1-5

    Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug

Study contacts

Contact information is provided by the study sponsor or research team.

Yixue Wang, Doctor

CONTACT

[email protected]

8613524669352

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2021
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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