Population Pharmacokinetics of Commonly Used Antimicrobial Agents in Children of Bacterial Meningitis With Augmented Renal Clearance
Overview
- Phase
- Not Applicable
- Intervention
- meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid
- Conditions
- Bacterial Meningitis
- Sponsor
- Shandong University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- The random plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
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.
Investigators
Wei Zhao
Professor; Head of department of clinical pharmacy and pharmacology
Shandong University
Eligibility Criteria
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.
Arms & Interventions
Treatment(meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid)
The use of antimicrobial agents depends on the clinical practice.
Intervention: meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid
Outcomes
Primary Outcomes
The random plasma and cerebrospinal fluid drug concentration of meropenem，vancomycin，ceftazidime，ceftriaxone，ceftizoxime，linezolid.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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 Outcomes
- clinical response(Through study completion, an average of 14 days)