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

• Conditions: Central Nervous System Infection
• Interventions: Other: Children with the usage of anti-infective drugs

• Registration Number: NCT03960905
• Lead Sponsor: Wei Zhao

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 Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-04-27
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-22
• Last Update Submitted: 2019-05-22
• Study First Posted: 2019-05-23
• Last Update Posted: 2019-05-23
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with the usage of anti-infective drugs	Children with the usage of anti-infective drugs	in conformity with the clinical practice

Primary Outcome Measures

Name	Time	Method
maximum concentration (Cmax)	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

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

Trial Locations

Locations (1)

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