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

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.

Study Overview

• Status: Recruiting
• Conditions: Bacterial Meningitis; Augmented Renal Clearance
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Wei Zhao, Phd; Phone Number: 86053188383308; Email: zhao4wei2@hotmail.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400014
      • Recruiting
      • Children's Hospital of Chongqing Medical University
      • Contact: Wei Zhao, Phd; Phone Number: 86053188383308; Email: zhao4wei2@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children (2 months-18 years) of bacterial meningitis with augmented renal clearance

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: Children's Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): January 20, 2026
• Study Completion (Anticipated): March 20, 2026

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 10, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Bacterial Infections; Bacterial Infections and Mycoses; Central Nervous System Bacterial Infections; Meningitis; Meningitis, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Vancomycin; Linezolid; Ceftriaxone; Meropenem; Ceftazidime; Ceftizoxime
• Other Study ID Numbers: 2021-ARC-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No