Population Pharmacokinetics of Commonly Used Antimicrobial Agents in Children of Bacterial Meningitis With Augmented Renal Clearance

Recruiting

• Conditions: Bacterial Meningitis; Augmented Renal Clearance
• Interventions: Drug: meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid

• Registration Number: NCT04771884
• Lead Sponsor: Shandong University

Brief Summary

The investigator's purpose is to study the population pharmacokinetics of commonly used antimicrobial agents in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility.

Detailed Description

The investigator's purpose is to study the population pharmacokinetics of meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and linezolid in children of bacterial meningitis with augmented renal clearance and assess dosage individualization feasibility. In this study, the investigator will detect drug concentration in both plasma and cerebrospinal fluid to construct population pharmacokinetics.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-02-20
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-25
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-10
• Last Update Posted: 2021-04-13
• Primary Completion: 2026-01-20
• Study Completion: 2026-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Children have been diagnosed with bacterial meningitis with augmented renal clearance (eGFR ≥ 160 mL/(min*1.73m2));
• Age: 2 months-18 years;
• Meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and/ or linezolid used as part of regular treatment;
• Meropenem, vancomycin, ceftazidime, ceftriaxone, ceftizoxime and linezolid was administered intravenously.

Exclusion Criteria

• Patients who die within the treatment cycle;
• Severe congenital malformation;
• Receive other systemic experimental drug therapy;
• Other factors that the researchers consider unsuitable for inclusion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment(meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid)	meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid	The use of antimicrobial agents depends on the clinical practice.

Primary Outcome Measures

Name	Time	Method
The random plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.	at (0.5-10) hours after intravenous administration	To detect the random plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid after intravenous administration.
The trough plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.	at 1-2 hours before the next administration	To detect the trough plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid after intravenous administration.
The peak plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.	at (5-10) minutes after intravenous administration	To detect the peak plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid after intravenous administration.

Secondary Outcome Measures

Name	Time	Method
clinical response	Through study completion, an average of 14 days	Blood routine examination, cerebrospinal fluid routine examination and infection indicators (C-reaction protein, procalcitonin)

Trial Locations

Locations (1)

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China