Sepsis Clinical Trial
Official title:
Pharmacokinetics and Pharmacodynamics of Ceftazidime Avitbatan Sodium in Children With Severe Infection
NCT number | NCT04961580 |
Other study ID # | fdpicu-23 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2022 |
Est. completion date | June 1, 2024 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | June 1, 2024 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Months to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Children's hosptial of fudan university | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Day 1-5 | |
Secondary | 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. | Day 1-5 | |
Secondary | 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 | Day 1-5 | |
Secondary | 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 | Day1-5 | |
Secondary | 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 | Day1-5 |
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