A Study the Population Pharmacokinetics of Children Receiving the Anti-infective Drugs for Treatment of Infectious Disease in Central Nervous System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Central Nervous System Infection
- Sponsor
- Wei Zhao
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- maximum concentration (Cmax)
- Last Updated
- 6 years ago
Overview
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.
Investigators
Wei Zhao
Professor; Head of department of clinical pharmacy and pharmacology
Shandong University
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.).
Outcomes
Primary Outcomes
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 Outcomes
- time to achieve maximum concentration (Tmax)(up to 4 weeks)