Back to resultsOptimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment
Primary Purpose
Encephalitis, Meningitis, Meningoencephalitis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Types of etiological diagnostic methods
Sponsored by
About this trial
This is an interventional diagnostic trial for Encephalitis
Eligibility Criteria
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
Sites / Locations
- Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
- The Second Affiliated Hospital of Soochow University
- The First Affiliated Hospital of Soochow University
- Wuxi No.5 People's Hospital
- Shanghai Sixth People's Hospital
- Shanghai Blue Cross Brain HospitalRecruiting
- People's Hospital of Zhuji, Zhejiang Province
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group of mNGS
Group of PCR
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Mortality rate at 1 year
Mortality rate at 1 year
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04946682
Brief Title
Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment
Official Title
Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
April 14, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wen-hong Zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis, Meningitis, Meningoencephalitis, Next-Generation Sequencing, Polymerase Chain Reaction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
484 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group of mNGS
Arm Type
Experimental
Arm Title
Group of PCR
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Types of etiological diagnostic methods
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change Modified Rankin Scale (mRS) at 1 year
Description
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
Time Frame
mRS should be measured at 1 year
Secondary Outcome Measure Information:
Title
Mortality rate at 1 year
Description
Mortality rate at 1 year
Time Frame
Mortality rate at 1 year
Other Pre-specified Outcome Measures:
Title
Time required from 1 day of admission to the initiation of the target treatment
Description
The time required for the patients to get the target treatment from 1 day of admission.
Time Frame
Baseline (The time point of getting the target treatment - the time point of admission)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanliang Zhang
Phone
13815440366
Email
swinburn@163.com
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanlin Zhang
Phone
13771710630
Email
zhangyanlin0012006@163.com
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tingting Feng
Phone
13771815873
Email
fengting3@163.com
Facility Name
Wuxi No.5 People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214016
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renfang Chen
Phone
13621519216
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Cai
Phone
18817821207
Email
lilytsai1990@163.com
Facility Name
Shanghai Blue Cross Brain Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201101
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinghua Ye
Phone
15316925807
Email
1271648050@qq.com
Facility Name
People's Hospital of Zhuji, Zhejiang Province
City
Zhuji
State/Province
Zhejiang
ZIP/Postal Code
311899
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heqing Huang
Phone
13858516315
Email
zjganran@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
34998377
Citation
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.
Results Reference
derived
Learn more about this trial
Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment
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