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

ConditionsSepsisAntibiotic Reaction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-18
SponsorChildren's Hospital of Fudan University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Children who are admitted in the pediatric intensive care unit receiving ceftazidime avitbatan sodium

Disqualifiers

No Informed Consent signed

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Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Ceftazidime avitbatan sodiumt group1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 1-5

Secondary outcomes

1

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.

Time frame
Day 1-5
2

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

Time frame
Day 1-5
3

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

Time frame
Day1-5
4

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

Time frame
Day1-5

Other outcomes

Sponsors and contacts

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Children's Hospital of Fudan University

Lead sponsor

Source ClinicalTrials.gov
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