- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03960905
A Study the Population Pharmacokinetics of Children of Infectious Disease in Central Nervous System
May 22, 2019 updated by: Wei Zhao
A Study the Population Pharmacokinetics of Children Receiving the Anti-infective Drugs for Treatment of Infectious Disease in Central Nervous System
The investigators aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious disease in central nervous system.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhao Wei, Ph.D
- Phone Number: 053188383308
- Email: zhao4wei2@hotmail.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100045
- Recruiting
- Department of Infectious Diseases, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
-
Contact:
- Liu Gang, Ph.D.
- Phone Number: 010-59617011
- Email: liugang@bch.com.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 weeks to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children with infections of center nurous system therapies.
Description
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.).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Children with the usage of anti-infective drugs
in conformity with the clinical practice
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
April 27, 2019
First Submitted That Met QC Criteria
May 22, 2019
First Posted (Actual)
May 23, 2019
Study Record Updates
Last Update Posted (Actual)
May 23, 2019
Last Update Submitted That Met QC Criteria
May 22, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-CNSI-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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