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Nanopore sequencing technique for the diagnosis of central nervous system infections

Nanopore sequencing technique for the diagnosis of central nervous system infections

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900027620
Enrollment
Unknown
Registered
2019-11-21
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

central nervous system infectious disease

Interventions

Gold Standard:The diagnostic criteria of encephalitis and meningitis are as described in the inclusion criteria.
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Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 90 Years

Inclusion criteria

Inclusion criteria: Case definitions for encephalitis: Major criteria (required) Patients presenting to medical attention with altered mental status (decreased or altered level of consciousness or personality change) lasting >=24 hrs with no alternative cause identified, and/or generalized or partial seizures not fully attributable to a pre-existing seizure disorder or a simple febrile seizure. Minor criteria (>=2 points) Documented fever >=38 degree C within the 72 hrs before or after presentation New onset of focal neurologic findings CSF WBC count >=5/cubic mm Abnormality of brain parenchyma on neuroimaging suggestive of encephalitis that is either new from prior studies or appears acute in onset Abnormality on EEG that is consistent with encephalitis and not attributable to another cause; Case definitions for meningitis Patients presenting to medical attention with at least two of the four symptoms of headache, fever (documented fever >=38 degree C within the 72 hrs before or after presentation), neck stiffness, decreased level of consciousness (defined by a Glasgow Coma Scale score below 14) CSF white blood cell count >= 5/cubic mm.

Exclusion criteria

Exclusion criteria: Exclusion criteria for encephalitis: <=28 days of age; Non-infectious encephalitis, such as autoimmune disorders, paraneoplastic syndromes, NMOSD, neuropsychiatric involvement of rheumatic diseases HIV or syphilis infection History of recent (within 4 weeks before the onset of disease) vaccination Meningitis without clinical brain parenchyma involvement Absolute contraindications for lumbar puncture; Traumatic LP with obvious blood-contaminated CSF Pregnancy Refusal to sign the informed consent. Exclusion criteria for meningitis: <=28 days of age; HIV or syphilis infection Meningeal malignancy confirmed by CSF cytology Traumatic LP with obvious blood-contaminated CSF Pregnancy Refusal to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
sensitivity,specificity,mistake diagnostic rate,pmission diagnostic rate,positive predictive value,negative predictive value,accuracy,Youden index,odd product,positive likelihood ratio,negative likelyhood ratio;

Countries

China

Contacts

Public ContactWei Li

People's Hospital of Zhengzhou University, He'nan Provincial People's Hospital

liwein@zzu.edu.cn+86 13939061069

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026