Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment
1 other identifier
interventional
484
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 14, 2021
CompletedFirst Submitted
Initial submission to the registry
May 27, 2021
CompletedFirst Posted
Study publicly available on registry
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedJuly 1, 2021
June 1, 2021
1 year
May 27, 2021
June 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The change Modified Rankin Scale (mRS) 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
mRS should be measured at 1 year
Secondary Outcomes (1)
Mortality rate at 1 year
Mortality rate at 1 year
Other Outcomes (1)
Time required from 1 day of admission to the initiation of the target treatment
Baseline (The time point of getting the target treatment - the time point of admission)
Study Arms (2)
Group of mNGS
EXPERIMENTALGroup of PCR
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wen-hong Zhanglead
Study Sites (7)
Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
Nanjing, Jiangsu, 210001, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Wuxi No.5 People's Hospital
Wuxi, Jiangsu, 214016, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233, China
Shanghai Blue Cross Brain Hospital
Shanghai, Shanghai Municipality, 201101, China
People's Hospital of Zhuji, Zhejiang Province
Zhuji, Zhejiang, 311899, China
Related Publications (1)
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.
PMID: 34998377DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- chairman of the infectious disease department
Study Record Dates
First Submitted
May 27, 2021
First Posted
July 1, 2021
Study Start
April 14, 2021
Primary Completion
April 14, 2022
Study Completion
April 30, 2023
Last Updated
July 1, 2021
Record last verified: 2021-06