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

NCT04961580 | Recruiting

• 1 other identifier: fdpicu-23
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sepsis; Antibiotic Reaction

Outcome Measures

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

  Day 1-5

Secondary Outcomes (4)

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

  Day 1-5

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

  Day 1-5

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

  Day1-5

• Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter

  Day1-5

Study Arms (1)

Ceftazidime avitbatan sodiumt group

Children treated with ceftazidime avitbatan sodium in the pediatric intensive care unit will be enrolled in this group. Blood sample will be retained at various time intervals for pharmacokinetics.

Drug: Ceftazidime Avitbatan Sodium

Interventions

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.

Ceftazidime avitbatan sodiumt group

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• No Informed Consent signed
• Participate in other clinical trials

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's hosptial of fudan university

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guoping Lu, doctor

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yixue Wang, Doctor

CONTACT

8613524669352; yixuewang08@aliyun.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: July 14, 2021
• Study Start: October 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)