Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment

Meningitis Clinical Trial

Official title:

Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04946682
• Other study ID #: IMPROVE
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2021
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 484
• Est. completion date: April 30, 2023
• Est. primary completion date: April 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Encephalitis
• Meningitis
• Meningoencephalitis
• Next-Generation Sequencing
• Polymerase Chain Reaction

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine	Nanjing	Jiangsu
China	Shanghai Blue Cross Brain Hospital	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Wuxi No.5 People's Hospital	Wuxi	Jiangsu
China	People's Hospital of Zhuji, Zhejiang Province	Zhuji	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wen-hong Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	Mortality rate at 1 year	Mortality rate at 1 year	Mortality rate at 1 year