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

Overview

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

Full Title of Study: “A Study the Population Pharmacokinetics of Children Receiving the Anti-infective Drugs for Treatment of Infectious Disease in Central Nervous System”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: December 31, 2020

Detailed Description

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.

Interventions

  • Other: 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.

Arms, Groups and Cohorts

  • Children with the usage of anti-infective drugs
    • in conformity with the clinical practice

Clinical Trial Outcome Measures

Primary Measures

  • maximum concentration (Cmax)
    • Time Frame: up to 4 weeks
    • Cmax is a term used in pharmacokinetics refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.

Secondary Measures

  • time to achieve maximum concentration (Tmax)
    • Time Frame: up to 4 weeks
    • Tmax is the term used in pharmacokinetics to describe the time at which the Cmax is observed.

Participating in This Clinical Trial

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.).

Gender Eligibility: All

Minimum Age: 29 Days

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wei Zhao
  • Collaborator
    • Beijing Children’s Hospital
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Wei Zhao, Professor; Head of department of clinical pharmacy and pharmacology – Shandong University
  • Overall Contact(s)
    • Zhao Wei, Ph.D, 053188383308, zhao4wei2@hotmail.com

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