A Study the Population Pharmacokinetics of Children of Infectious Disease in Central Nervous System

NCT ID: NCT03960905

Last Updated: 2019-05-23

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

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-12-31

Brief Summary

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The investigators aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious disease in central nervous system.

Detailed Description

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The investigators aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious disease in central nervous system.In this study, the investigators will detect drug concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models.

Conditions

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Central Nervous System Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Children with the usage of anti-infective drugs

in conformity with the clinical practice

Children with the usage of anti-infective drugs

Intervention Type OTHER

According to the models of population pharmacokinetics,the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children.

Interventions

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Children with the usage of anti-infective drugs

According to the models of population pharmacokinetics,the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children.

Intervention Type OTHER

Other Intervention Names

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Cefepime (Maxipime®) ceftazidime meropenem (Mepem®)

Eligibility Criteria

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Inclusion Criteria

* Children (29 days-18 years old) with anti-infective therapy against infectious disease in central nervous system.
* Clinical symptoms: acute onset, fever (axillary temperature 38 ℃ or higher), headache, altered level of consciousness, vomiting, irritability, sleepiness, low muscle tone, seizures, before the fontanelle full or uplift, positive meningeal stimulation;
* Aboratory examination: CSF appearance change, CSF routine WBC \>100 per ml, CSF routine WBC 10-100 per ml, glucose \<40mg/dl, protein \>100mg/dl), positive detection of etiology (bacterial culture, antigen detection, gram staining).

Exclusion Criteria

* autoimmune encephalitis;
* central nervous system infection complicated with tumor;
* allergic to carbapenems or glycopeptide antibiotics;
* other cases not suitable for enrollment (small sample size, incomplete clinical data, etc.).
Minimum Eligible Age

29 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Children's Hospital

OTHER

Sponsor Role collaborator

Wei Zhao

OTHER

Sponsor Role lead

Responsible Party

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Wei Zhao

Professor; Head of department of clinical pharmacy and pharmacology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Infectious Diseases, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhao Wei, Ph.D

Role: CONTACT

053188383308

Facility Contacts

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Liu Gang, Ph.D.

Role: primary

010-59617011

Other Identifiers

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2019-CNSI-001

Identifier Type: -

Identifier Source: org_study_id

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