PK/PD of Ceftazidime Avitbatan Sodium in Children With Severe Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ceftazidime Avitbatan Sodium.
- Who it may be relevant to
- Registry conditions: Sepsis, Antibiotic Reaction. Basic parameters: 3 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pharmacokinetics and Pharmacodynamics of Ceftazidime Avitbatan Sodium in Children With Severe Infection
Overview
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.
Interventions
- Drug 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.
Primary outcome measures
- Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter [Time frame: Day 1-5]
Secondary outcome measures (4)
- Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter [Time frame: Day 1-5]
- AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter [Time frame: Day 1-5]
- AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter [Time frame: Day1-5]
- Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter [Time frame: Day1-5]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Children's hosptial of fudan university — Shanghai
Identifiers
NCT: NCT04961580 · fdpicu-23