Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment

Study Overview
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Brief Summary
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Encephalitis and meningitis are serious central nervous system diseases. There is currently a lack of comprehensive and accurate diagnosis and treatment pathways. Therefore, we conducted this multicenter, prospective, and randomized controlled study. It was designed to evaluate the diagnostic performance and its impact on the outcomes of the patients enrolled. As such, we came to the results of the optimal process of diagnosis and treatment strategy of encephalitis/meningeal syndromes with improved effective treatments.

Official Title
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Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment

Conditions
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Encephalitis, Meningitis, Meningoencephalitis, Next-Generation Sequencing, Polymerase Chain Reaction

Intervention / Treatment
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* Diagnostic Test: Types of etiological diagnostic methods


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with suspected meningitis : the patient has a new fever (>38.5℃), accompanied by ≥1 of the following manifestations： Stiff neck Change in state of consciousness Other signs of meningitis: such as meningeal irritation. Patients with suspected encephalitis: Unexplained changes in the state of consciousness for more than 24 hours (including lethargy, agitation, personality changes, etc.) or accompanied by recent memory impairment, with the following ≥1 manifestations: Fever during the course of the disease (≥ 38℃); (oral temperature) Convulsions or focal neurological symptoms; Increase in the number of cerebrospinal fluid cells (>4*10^6/L); Abnormal EEG that meets the manifestations of encephalitis and cannot be attributed to other reasons Imaging suggests encephalitis (CT or MRI) Have not received effective anti-infective treatment yet Have an identifiable address and live in the area during treatment. Suspected encephalitis/meningitis patients who are willing to participate in trial treatment and follow-up and can give informed consent (if the subject is illiterate, sign or hearing consent is required). Willing to comply with follow-up research procedures. Exclusion Criteria: Known breastfeeding or pregnancy Failure to comply with treatment or follow-up time; The researcher believes that there are any conditions (social or medical) that allow subjects to participate in unsafe; Participating in other clinical studies Insufficient cerebrospinal fluid or blood samples Clinically diagnosed infections, tumors or other neurological diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group of mNGS<br> | Diagnostic Test: Types of etiological diagnostic methods<br>* In Group of mNGS, all patients will be tested by meta next generation sequncing on admission, while patients in Group of PCR will be tested by polymerase chain reaction in accordance with the method in the guidelines.<br>|
| Experimental: Group of PCR<br> | Diagnostic Test: Types of etiological diagnostic methods<br>* In Group of mNGS, all patients will be tested by meta next generation sequncing on admission, while patients in Group of PCR will be tested by polymerase chain reaction in accordance with the method in the guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change Modified Rankin Scale (mRS) at 1 year | The Modified Rankin Scale at 1 year Grade Description 0 No symptoms Minor symptoms not interfering with lifestyle Symptoms that lead to some restriction in lifestyle, but do not interfere with the patients' ability to look after themselves Symptoms that restrict lifestyle and prevent totally independent living Symptoms that clearly prevent independent living, although the patient does not need constant care and attention Totally dependent, requiring constant help day and night | mRS should be measured at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate at 1 year | Mortality rate at 1 year | Mortality rate at 1 year |