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Optimal Encephalitis/Meningitis Roadmap Via Precise Diagnosis and Treatment

W

Wen-hong Zhang

Status

Unknown

Conditions

Polymerase Chain Reaction
Meningitis
Encephalitis
Meningoencephalitis
Next-Generation Sequencing

Treatments

Diagnostic Test: Types of etiological diagnostic methods

Study type

Interventional

Funder types

Other

Identifiers

NCT04946682
IMPROVE

Details and patient eligibility

About

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.

Enrollment

484 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

484 participants in 2 patient groups

Group of mNGS
Experimental group
Treatment:
Diagnostic Test: Types of etiological diagnostic methods
Group of PCR
Experimental group
Treatment:
Diagnostic Test: Types of etiological diagnostic methods

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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