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Establishment and implementation evaluation of a precise diagnostic system for central nervous system infections in children

Establishment and implementation evaluation of a precise diagnostic system for central nervous system infections in children

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400091177
Enrollment
Unknown
Registered
2024-10-22
Start date
2024-04-07
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

Central nervous system infection

Interventions

Pathogen diagnosis optimization strategy group:NA
Pathogen diagnosis routine strategy group:NA

Sponsors

Beijing Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: Project 1: Optimization and implementation evaluation of a multicenter strategy for pathogenic diagnosis of CNS infections in children. (1) suspected bacterial meningitis in children, in line with the World Health Organization (WHO) bacterial meningitis surveillance case classification criteria improved: ? 28 days after birth to 18 years old; ? acute onset of disease; ? fever (axillary temperature = 38 ° C) and or the following clinical signs: headache, altered consciousness, refusal to breastfeeding, vomiting, irritability, lethargy, hypotonia, convulsive episodes, fontanel full or bulging, more than one Clinical signs of meningitis; ? one of the following two conditions: cerebrospinal fluid routine WBC > 100 / ml; or cerebrospinal fluid routine WBC 10 ~ 100 / ml and changes in the appearance of cerebrospinal fluid or glucose 100mg / dl. (2) suspected childhood encephalitis criteria: ? 28 days to 18 years old; ? acute onset of the disease; ? fever and meet the one of the following Headache, vomiting, convulsions, impaired consciousness; ? Cerebrospinal fluid cell count =15/ml. Project 2: Construction and validation of a "host biomarker combined with clinical microbiology pathogen diagnostic model" for pediatric CNS infection. (1) suspected bacterial meningitis in children, in line with the World Health Organization (WHO) bacterial meningitis surveillance case classification criteria improved: ? 28 days after birth to 18 years old; ? acute onset of disease; ? fever (axillary temperature = 38 ° C) and or the following clinical signs: headache, altered consciousness, refusal to breastfeeding, vomiting, irritability, lethargy, hypotonia, convulsive episodes, fontanel full or bulging, more than one Clinical signs of meningitis; ? one of the following two conditions: cerebrospinal fluid routine WBC > 100 / ml; or cerebrospinal fluid routine WBC 10 ~ 100 / ml and changes in the appearance of cerebrospinal fluid or glucose 100mg / dl. (2) suspected childhood encephalitis criteria: ? 28 days to 18 years old; ? acute onset of the disease; ? fever and meet the one of the following Headache, vomiting, convulsions, impaired consciousness; ? Cerebrospinal fluid cell count =15/ml.

Exclusion criteria

Exclusion criteria: Project 1: Optimization and implementation evaluation of a multicenter strategy for pathogenic diagnosis of CNS infections in children. 1. cases of autoimmune encephalitis; 2. tumors with central nervous system involvement; 3. cases with bloody cerebrospinal fluid; 4. the volume of cerebrospinal fluid was less than 1ml; 5. Children who refused to be enrolled for various reasons; Project 2: Construction and validation of a "host biomarker combined with clinical microbiology pathogen diagnostic model" for pediatric CNS infection. 1. cases of autoimmune encephalitis; 2. tumors with central nervous system involvement; 3. cases with bloody cerebrospinal fluid; 4. the volume of cerebrospinal fluid was less than 1ml; 5. children who refused to be enrolled for various reasons; 6.those with a clear pathogenic diagnosis.

Design outcomes

Primary

MeasureTime frame
pathogen detection rate;

Secondary

MeasureTime frame
Total length of stay;clinical outcome;The duration of pathogen diagnosis;use of antibiotics;general expenses;Accuracy;Precision;Recall;F1 Score;

Countries

China

Contacts

Public ContactLiu Gang

Beijing Children's Hospital

liugangbch@sina.com+86 10 5963 7011

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026