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出境医 / 临床实验 / A Study the Population Pharmacokinetics of Children of Infectious Disease in Central Nervous System

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

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

Condition or disease Intervention/treatment
Central Nervous System Infection Other: Children with the usage of anti-infective drugs

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.
Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Study the Population Pharmacokinetics of Children Receiving the Anti-infective Drugs for Treatment of Infectious Disease in Central Nervous System
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
Children with the usage of anti-infective drugs
in conformity with the clinical practice
 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.
Other Names:
  • Cefepime (Maxipime®)
  • ceftazidime
  • meropenem (Mepem®)
Outcome Measures
Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
plasma and hemocyte

Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children with infections of center nurous system therapies.
Criteria

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.).
Contacts and Locations

Contacts
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Contact: Zhao Wei, Ph.D 053188383308 zhao4wei2@hotmail.com

Locations
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China, Beijing
Department of Infectious Diseases, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health Recruiting
Beijing, Beijing, China, 100045
Contact: Liu Gang, Ph.D.    010-59617011    liugang@bch.com.cn   
Sponsors and Collaborators
Wei Zhao
Beijing Children's Hospital
Tracking Information
First Submitted Date April 27, 2019
First Posted Date May 23, 2019
Last Update Posted Date May 23, 2019
Actual Study Start Date January 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 22, 2019) 		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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 22, 2019) 		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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study the Population Pharmacokinetics of Children of Infectious Disease in Central Nervous System
Official Title A Study the Population Pharmacokinetics of Children Receiving the Anti-infective Drugs for Treatment of Infectious Disease in Central Nervous System
Brief Summary 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 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
plasma and hemocyte
Sampling Method Probability Sample
Study Population Children with infections of center nurous system therapies.
Condition Central Nervous System Infection
Intervention 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.
Other Names:
  • Cefepime (Maxipime®)
  • ceftazidime
  • meropenem (Mepem®)
Study Groups/Cohorts Children with the usage of anti-infective drugs
in conformity with the clinical practice
Intervention: Other: Children with the usage of anti-infective drugs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 22, 2019) 		800
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.).
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03960905
Other Study ID Numbers 2019-CNSI-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Wei Zhao, Shandong University
Study Sponsor Wei Zhao
Collaborators Beijing Children's Hospital
Investigators Not Provided
PRS Account Shandong University
Verification Date May 2019

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