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Status unknownNCT04946682Updated Jul 1, 2021

Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment

An interventional study of Types of etiological diagnostic methods in Encephalitis, Meningitis and Meningoencephalitis, sponsored by Wen-hong Zhang. Status unknown at 7 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-07-01.

Sponsored by Wen-hong Zhang · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
484
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study 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.

02

Conditions studied

  • Encephalitis
  • Meningitis
  • Meningoencephalitis
  • Next-Generation Sequencing
  • Polymerase Chain Reaction
03

In context

Encephalitis

125 studies on the registry are indexed under Encephalitis; 33 are open to participants now.

This study's planned enrollment of 484 is above the median of 55 across 62 interventional studies indexed under Encephalitis.

Browse Encephalitis studies →

Lead sponsor

Wen-hong Zhang is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (if the subject is illiterate, sign or hearing consent is required).
  • Willing to comply with follow-up research procedures.

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
484 participants (estimated)

Study arms

  • Experimental
    Group of mNGS

    Diagnostic Test: Types of etiological diagnostic methods

  • Experimental
    Group of PCR

    Diagnostic Test: Types of etiological diagnostic methods

Interventions

  • Diagnostic testTypes 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.

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What researchers measure

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

    Time frame: mRS should be measured at 1 year

Secondary outcomes

  1. Mortality rate at 1 year

    Mortality rate at 1 year

    Time frame: Mortality rate at 1 year

Other outcomes

  1. 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.

    Time frame: Baseline (The time point of getting the target treatment - the time point of admission)

07

Study locations

1 of 7 sites recruiting
  • Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
    Nanjing, Jiangsu 210001, China
    Not yet recruiting
  • The Second Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215004, China
    Not yet recruiting
  • The First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu 215006, China
    Not yet recruiting
  • Wuxi No.5 People's Hospital
    Wuxi, Jiangsu 214016, China
    Not yet recruiting
    • Renfang Chen · Contact13621519216
  • Shanghai Sixth People's Hospital
    Shanghai, Shanghai 200233, China
    Not yet recruiting
  • Shanghai Blue Cross Brain Hospital
    Shanghai, Shanghai 201101, China
    Recruiting
  • People's Hospital of Zhuji, Zhejiang Province
    Zhuji, Zhejiang 311899, China
    Not yet recruiting
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References and documents

Publications

  • 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. PubMed 34998377 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2021 (actual). Primary completion is estimated for Apr 2022, 12 months after the start.

Of 18 interventional studies with no phase under Encephalitis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 33. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 27, 2021
First posted
Jul 1, 2021
StartActual
Apr 14, 2021
Primary completionEst.
Apr 14, 2022
CompletionEst.
Apr 30, 2023
Last update
Jul 1, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04946682
Lead sponsor
Wen-hong Zhang
Responsible party
Wen-hong Zhang (chairman of the infectious disease department, Huashan Hospital) — Sponsor-investigator
First posted
Jul 1, 2021
Start date
Apr 14, 2021
Primary completion
Apr 14, 2022 (estimated)
Completion
Apr 30, 2023 (estimated)
Last update
Jul 1, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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