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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03960905
Enrollment
800
Registered
2019-05-23
Start date
2019-01-01
Completion date
2020-12-31
Last updated
2019-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Infection

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.

Interventions

OTHERChildren 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.

Sponsors

Beijing Children's Hospital
CollaboratorOTHER
Wei Zhao
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
29 Days to 18 Years
Healthy volunteers
No

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.).

Design outcomes

Primary

MeasureTime frameDescription
maximum concentration (Cmax)up to 4 weeksCmax 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

MeasureTime frameDescription
time to achieve maximum concentration (Tmax)up to 4 weeksTmax is the term used in pharmacokinetics to describe the time at which the Cmax is observed.

Countries

China

Contacts

Primary ContactZhao Wei, Ph.D
zhao4wei2@hotmail.com053188383308

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026