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

Bacterial Meningitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04771884
• Other study ID #: 2021-ARC-002
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: March 20, 2026

Study information

• Verified date: April 2021
• Source: Shandong University
• Contact: Wei Zhao, Phd
• Phone: 86053188383308
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 20, 2026
• Est. primary completion date: January 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Augmented Renal Clearance
• Bacterial Meningitis
• Meningitis
• Meningitis, Bacterial
• Meningococcal Infections

Intervention

Drug:
• meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid
The use of antimicrobial agents depends on the clinical practice

Locations

Country	Name	City	State
China	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Shandong University	Children's Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

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