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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04771884
Other study ID # 2021-ARC-002
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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