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Establishment of a diagnostic model for tuberculous meningitis based on untargeted quantitative proteomics and biomarkers such as apolipoprotein E and its clinical diagnostic value assessment

Establishment of a diagnostic model for tuberculous meningitis based on untargeted quantitative proteomics and biomarkers such as apolipoprotein E and its clinical diagnostic value assessment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119815
Enrollment
Unknown
Registered
2026-03-04
Start date
2025-02-19
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

Tuberculous meningitis

Interventions

Gold Standard:Diagnostic criteria for tuberculous meningitis: According to the international diagnostic criteria for tuberculous meningitis, it is classified as confirmed, highly likely, and possible
positive mycobacterium culture in CSF
positive nucleic acid test for Mycobacterium tuberculosis in CSF. 2. Tuberculous pathological changes are found in the brain or spinal cord, acid-fast staining is positive, and there are clinical mani
(2) A clinical score of more than 10 points (no cranial imaging examination)
or a clinical score of more than 12 points (with cranial imaging examination)
(3) At least 2 points in CSF or imaging scores
(4) Exclusion of other meningitis. Possible TBM: (1) For patients with head CT or head MRI examination, the clinical score is 6-11 points
(2) For those without head CT or head MRI examination, the clinical score is 6-9 points, and at the same time, other diseases are excluded. Note: If head CT, head MRI examination, and lumbar puncture

Sponsors

Beijing Chest Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Emergency and inpatient patients with suspected TBM at Beijing Chest Hospital. 2.Patients with TBM who have received anti-tuberculosis treatment for less than 2 weeks, and patients with other central nervous system infections who have received treatment for less than 1 week. 3. There are no contraindications for lumbar puncture. 4. The patients have agreed to participate in the study and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with possible tuberculous meningitis. 2. Patients whose diagnosis is unclear. 3. Infections in the brain caused by brain trauma or invasive intracranial examinations. 4. Long-term use of glucocorticoids, non-steroidal anti-inflammatory drugs, or immunosuppressants.

Design outcomes

Primary

MeasureTime frame
Accuracy;

Secondary

MeasureTime frame
Sensitivity;Specificity;

Countries

China

Contacts

Public ContactMailing Huang

Beijing Chest Hospital, Capital Medical University

huangmailing@163.com+86 137 2004 6915

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026