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

W

Wei Zhao

Status

Unknown

Conditions

Central Nervous System Infection

Treatments

Other: Children with the usage of anti-infective drugs

Study type

Observational

Funder types

Other

Identifiers

NCT03960905
2019-CNSI-001

Details and patient eligibility

About

The investigators aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious disease in central nervous system.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

29 days to 18 years old

Volunteers

No Healthy Volunteers

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.).

Trial design

800 participants in 1 patient group

Children with the usage of anti-infective drugs
Description:
in conformity with the clinical practice
Treatment:
Other: Children with the usage of anti-infective drugs

Trial contacts and locations

0

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Central trial contact

Zhao Wei, Ph.D

Data sourced from clinicaltrials.gov

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