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

Study Overview
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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.

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

Conditions
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Central Nervous System Infection

Intervention / Treatment
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* Other: Children with the usage of anti-infective drugs


Participation Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with the usage of anti-infective drugs<br>in conformity with the clinical practice | Other: Children with the usage of anti-infective drugs<br>* According to the models of population pharmacokinetics,the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children.<br>* Other names: meropenem (Mepem®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum concentration (Cmax) | 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) | Tmax is the term used in pharmacokinetics to describe the time at which the Cmax is observed. | up to 4 weeks |