The impact of fast tissue based assay on clinical outcomes in patients with meningoencephalitis: a randomized controlled trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500102371

Enrollment

Unknown

Registered

2025-05-13

Start date

2025-06-01

Completion date

Unknown

Last updated

2025-05-19

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

Conditions

meningoencephalitis

Interventions

CMAT group :Conventional Microbiological and Autoantibody Tests

CMAT+FTBA group :Conventional Microbiological and Autoantibody Tests and Fast TBA

Eligibility

Sex/Gender

All

Age

14 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with undetermined etiology who have not received targeted treatment, and the time from symptom onset is 38.5°C, oral temperature) accompanied by >=1 of the following: 1) Neck stiffness; 2) Altered mental status; 3) Other meningeal signs (e.g., Kernig's or Brudzinski's sign). (2) Encephalitis: Unexplained altered mental status lasting >24 hours (including lethargy, irritability, personality changes, etc.) or recent memory impairment, with >=1 of the following: 1) Fever (>=38°C, oral temperature) during the course of illness; 2) Seizures or focal neurological deficits; 3) Increased CSF white blood cell count (>4×106/L); 4) EEG abnormalities consistent with encephalitis not attributable to other causes; 5) Imaging findings (CT or MRI) suggestive of encephalitis. 3. Age >=14 years and <=80 years, regardless of gender. 4. Able to understand and sign informed consent, willing to participate in the study, and comply with follow-up procedures.

Exclusion criteria

Exclusion criteria: 1. Does not meet the diagnostic criteria for the disease in terms of disease course, clinical presentation, or auxiliary tests. 2. Contraindications to lumbar puncture. 3. Pregnant patients. 4. Participation in another clinical trial within the past 3 months.

Design outcomes

Primary

Measure	Time frame
Time to definitive etiological diagnosis;Time to initiation of targeted treatment;Improvement in mRS at 28 days;Improvement in mRS at 6 months;Improvement in GCS at 28 days;Improvement in GCS at 6 months;	—

Secondary

Measure	Time frame
Improvement in EQ-5D-5L scores at 6 months;mortality rate;Antimicrobial usage intensity;Length of hospital stay;Hospitalization costs;	—

Countries

China

Contacts

Public ContactXiangjun Chen

Huashan Hospital, Fudan University

xiangjchen@fudan.edu.cn+86 21 5288 8159

Outcome results

None listed

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