Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

484 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-14

Study Completion Date

2023-04-30

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.

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Detailed Description

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Conditions

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Encephalitis Meningitis Meningoencephalitis Next-Generation Sequencing Polymerase Chain Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group of mNGS

Group Type EXPERIMENTAL

Types of etiological diagnostic methods

Intervention Type 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.

Group of PCR

Group Type EXPERIMENTAL

Types of etiological diagnostic methods

Intervention Type 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.

Interventions

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Types of etiological diagnostic methods

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.

Intervention Type DIAGNOSTIC_TEST

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：

1. Stiff neck
2. Change in state of consciousness
3. 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:

1. Fever during the course of the disease (≥ 38℃); (oral temperature)
2. Convulsions or focal neurological symptoms;
3. Increase in the number of cerebrospinal fluid cells (\>4\*10\^6/L);
4. Abnormal EEG that meets the manifestations of encephalitis and cannot be attributed to other reasons
5. 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Wen-hong Zhang

chairman of the infectious disease department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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