Clinical trial NCT04946682: Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment
Official title: Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Encephalitis
Meningitis
Meningoencephalitis
Next-Generation Sequencing
Polymerase Chain Reaction
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: The change Modified Rankin Scale (mRS) at 1 year
timeFrame: mRS should be measured at 1 year
Secondary outcomes:
measure: Mortality rate at 1 year
timeFrame: Mortality rate at 1 year
Other outcomes:
measure: Time required from 1 day of admission to the initiation of the target treatment
timeFrame: Baseline (The time point of getting the target treatment - the time point of admission)
Locations:
city: Nanjing
country: China
facility: Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi No.5 People's Hospital
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Blue Cross Brain Hospital
state: Shanghai
city: Zhuji
country: China
facility: People's Hospital of Zhuji, Zhejiang Province
state: Zhejiang
Study officials:
References:
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.