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Clinical Trials in China / NCT04961580
Recruiting Observational

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

NCT04961580 · tracked via the Priya Life Science China tracker
Sponsor
Children's Hospital of Fudan University
Phase
Observational
Started
2022-10-01
Last updated
2026-03-16

Condition(s) studied

SepsisAntibiotic Reaction

Investigational drug(s) / intervention(s)

Ceftazidime Avitbatan Sodium

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.

Study 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.

Eligibility

Sex
ALL
Min age
3 Months
Max age
18 Years
Healthy volunteers
No
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 outcome measure(s)

  • Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter — Day 1-5
    Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug

Trial sites (1)

FacilityCityRegionStatus
Children's hosptial of fudan university Shanghai Shanghai Municipality Recruiting

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Other trials for the same condition

Effect of Xuebijing InjecTion on Outcomes in Sepsis Patients Under Real-World Conditions（EXIT-SEP REAL） Starting soon
Effect of Heart Rate Control With Ivabradine on Hemodynamic in Patients With Sepsis Recruiting
Blood DdPCR for Early Identification and Dynamic Surveillance of Pathogenic Bacteria in ICU Septic Patients: a Single-centre, Prospective, Observational Study Recruiting
Efficacy of Anisodamine Hydrobromide Combined With Low-molecular-weight Heparin in the Treatment of Patients With Sepsis Recruiting
Clinical Features and Outcomes of CBP Versus Non-CBP in Septic Children Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04961580 on ClinicalTrials.gov ↗ ← All trials in China