Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment

Not Applicable

• Conditions: Meningoencephalitis; Encephalitis; Meningitis; Next-Generation Sequencing; Polymerase Chain Reaction
• Interventions: Diagnostic Test: Types of etiological diagnostic methods

• Registration Number: NCT04946682
• Lead Sponsor: Wen-hong Zhang

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-14
• Study First Submitted: 2021-05-27
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-29
• Last Update Submitted: 2021-06-29
• Study First Posted: 2021-07-01
• Last Update Posted: 2021-07-01
• Primary Completion: 2022-04-14
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 484

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group of mNGS	Types of etiological diagnostic methods	-
Group of PCR	Types of etiological diagnostic methods	-

Primary Outcome Measures

Name	Time	Method
The change Modified Rankin Scale (mRS) at 1 year	mRS should be measured at 1 year	The Modified Rankin Scale at 1 year Grade Description 0 No symptoms; 1. Minor symptoms not interfering with lifestyle; 2. Symptoms that lead to some restriction in lifestyle, but do not interfere with the patients' ability to look after themselves; 3. Symptoms that restrict lifestyle and prevent totally independent living; 4. Symptoms that clearly prevent independent living, although the patient does not need constant care and attention; 5. Totally dependent, requiring constant help day and night

Secondary Outcome Measures

Name	Time	Method
Mortality rate at 1 year	Mortality rate at 1 year	Mortality rate at 1 year

Trial Locations

Locations (7)

Wuxi No.5 People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

People's Hospital of Zhuji, Zhejiang Province; 🇨🇳 Zhuji, Zhejiang, China

The Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Shanghai Blue Cross Brain Hospital; 🇨🇳 Shanghai, Shanghai, China

Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine; 🇨🇳 Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China