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The clinical value of a new detection method based on probe capture technology in the diagnosis of central nervous system infectious diseases

The clinical value of a new detection method based on probe capture technology in the diagnosis of central nervous system infectious diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113708
Enrollment
Unknown
Registered
2025-12-02
Start date
2024-06-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Central nervous system infectious diseases

Interventions

Suspected Central Nervous System Infectious Diseases Group:No interventions.

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Presence of symptoms or signs consistent with central nervous system infection (one or more): fever, headache, vomiting, seizures, focal neurological deficits, behavioral abnormalities, impaired consciousness, meningeal irritation signs, etc.; 2. Age>=18 years; 3. Completion of lumbar puncture with successful collection of sufficient cerebrospinal fluid (CSF); 4. Fulfillment of at least one of the following criteria: a. Elevated intracranial pressure (>200 mmH2O); b. Increased CSF white blood cell count (>5 × 106/L); c. Elevated CSF protein level (>0.45 g/L); d. Decreased CSF glucose level (10 × 10?/L with neutrophil proportion >80%; g. Neuroimaging suggestive of possible infection; h. Failure to meet any of the above seven criteria, but effective response to empirical anti-infection therapy.

Exclusion criteria

Exclusion criteria: 1. Patient refusal of lumbar puncture, presence of contraindications to lumbar puncture, or insufficient cerebrospinal fluid (CSF) obtained; 2. Confirmed diagnosis of infectious diseases in other systems or non-infectious central nervous system diseases (e.g., autoimmune encephalitis, tumors, cerebrovascular disorders, etc.); 3. Severely incomplete clinical information; 4. Final diagnosis not confirmed with poor response to empirical anti-infection therapy.

Design outcomes

Primary

MeasureTime frame
Cerebrospinal Fluid Pathogen Detection results;Sensitivity (true positive rate);Specificity (true negative rate);Accuracy (crude agreement rate);

Secondary

MeasureTime frame
False positive rate;False negative rate;Youden index;Likelihood ratio;Additional detection rate;ROC curve;

Countries

China

Contacts

Public ContactZhen Hong

West China Hospital, Sichuan University

hongzhengoog@aliyun.com+86 189 8060 5818

Outcome results

None listed

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