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

NCT ID: NCT04771884

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2026-03-20

Brief Summary

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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

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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.

Conditions

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Bacterial Meningitis Augmented Renal Clearance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment(meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid)

The use of antimicrobial agents depends on the clinical practice.

meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid

Intervention Type DRUG

The use of antimicrobial agents depends on the clinical practice

Interventions

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meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid

The use of antimicrobial agents depends on the clinical practice

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Wei Zhao

Professor; Head of department of clinical pharmacy and pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Zhao, Phd

Role: CONTACT

86053188383308

Facility Contacts

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Wei Zhao, Phd

Role: primary

86053188383308

Other Identifiers

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2021-ARC-002

Identifier Type: -

Identifier Source: org_study_id

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