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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04771884

Enrollment

300

Registered

2021-02-25

Start date

2020-10-01

Completion date

2026-03-20

Last updated

2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Augmented Renal Clearance, Bacterial Meningitis

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.

Interventions

DRUGmeropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid

The use of antimicrobial agents depends on the clinical practice

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Months to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Secondary

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

Countries

China

Contacts

Primary ContactWei Zhao, Phd

zhao4wei2@hotmail.com86053188383308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026