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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group of mNGS | Experimental |
| |
| Group of PCR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Types of etiological diagnostic methods | Diagnostic Test | 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. |
| 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
| mRS should be measured at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate at 1 year | Mortality rate at 1 year | Mortality rate at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time required from 1 day of admission to the initiation of the target treatment | The time required for the patients to get the target treatment from 1 day of admission. | Baseline (The time point of getting the target treatment - the time point of admission) |
Inclusion Criteria:
Patients with suspected meningitis : the patient has a new fever (>38.5℃), accompanied by ≥1 of the following manifestations:
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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine | Not yet recruiting | Nanjing | Jiangsu | 210001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34998377 | Derived | Zhang Y, Zhang H, Deng B, Lin K, Jin L, Liu X, Zhang Y, Chen X, Zhang Y, Lu S, Huang H, Wang Q, Feng T, Zhao W, Xue Q, Chen R, Zhang J, Qian X, Chen L, Ai J, Chen X, Zhang W. Optimal encephalitis/meningitis roadmap via precise diagnosis and treatment (IMPROVE): a study protocol for a randomized controlled trial. BMC Infect Dis. 2022 Jan 8;22(1):40. doi: 10.1186/s12879-021-06943-6. |
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| ID | Term |
|---|---|
| D004660 | Encephalitis |
| D008581 | Meningitis |
| D008590 | Meningoencephalitis |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
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| The Second Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | Jiangsu | 215004 | China |
|
| The First Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | Jiangsu | 215006 | China |
|
| Wuxi No.5 People's Hospital | Not yet recruiting | Wuxi | Jiangsu | 214016 | China |
|
| Shanghai Sixth People's Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | 200233 | China |
|
| Shanghai Blue Cross Brain Hospital | Recruiting | Shanghai | Shanghai Municipality | 201101 | China |
|
| People's Hospital of Zhuji, Zhejiang Province | Not yet recruiting | Zhuji | Zhejiang | 311899 | China |
|
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |