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

Sponsor

Shandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04771884

Collaborator

Children's Hospital of Chongqing Medical University (Other)

300

Enrollment

Location

65.6

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Meningitis Augmented Renal Clearance	Drug: meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid

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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Jan 20, 2026

Anticipated Study Completion Date :

Mar 20, 2026

Arms and Interventions

Arm	Intervention/Treatment
Treatment(meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid) The use of antimicrobial agents depends on the clinical practice.	Drug: meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid The use of antimicrobial agents depends on the clinical practice

Arm

Intervention/Treatment

Treatment(meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid)

The use of antimicrobial agents depends on the clinical practice.

Drug: meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid

The use of antimicrobial agents depends on the clinical practice

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 18 Years

Sexes Eligible for Study:

All

Accepts 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.