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

NCT04771884 | Recruiting FDA Drug

• 1 other identifier: 2021-ARC-002
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Meningitis; Augmented Renal Clearance

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• clinical response

  Through study completion, an average of 14 days

Study Arms (1)

Treatment(meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid)

The use of antimicrobial agents depends on the clinical practice.

Drug: meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid

Interventions

meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid DRUG

The use of antimicrobial agents depends on the clinical practice

Treatment(meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid)

Eligibility Criteria

• Age: 2 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients who die within the treatment cycle;
• Severe congenital malformation;
• Receive other systemic experimental drug therapy;

Sponsors & Collaborators

• Shandong University: lead
• Children's Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

MeSH Terms

Conditions

Meningitis, Bacterial

Condition Hierarchy (Ancestors)

Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Central Study Contacts

Wei Zhao, Phd

CONTACT

86053188383308; zhao4wei2@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Head of department of clinical pharmacy and pharmacology

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: February 25, 2021
• Study Start: October 1, 2020
• Primary Completion: January 20, 2026
• Study Completion: March 20, 2026
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

CN (1)