Diagnostic test of FilmArray Meningitis/Encephalitis (ME) Panel for pathogens in central nervous system infection

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000038045

Enrollment

Unknown

Registered

2020-09-09

Start date

2020-09-14

Completion date

Unknown

Last updated

2020-11-24

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

Conditions

central nervous system infection

Interventions

Gold Standard:If one of the following is met: Cerebrospinal fluid (CSF) smear detected the pathogen

Etiological culture

Histopathology revealed the pathogen

The titer of double CSF antibody was more than 4 times higher

The pathogen nucleic acid was detected in cerebrospinal fluid.

Index test:FilmArray&#32

Meningitis/Encephalitis&#32

(ME)&#32

Panel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with clinical manifestations of central nervous system infection, such as fever, headache, vomiting or changes in consciousness, and neuropositional signs; (2) In the opinion of the competent physician, patients with central nervous system infection cannot be excluded.

Exclusion criteria

Exclusion criteria: (1) Central nervous system infection caused by trauma; (2) Nosocomial central nervous system infection; (3) Other circumstances in which the informed consent or the researcher's judgment is not appropriate to be enrolled.

Design outcomes

Primary

Measure	Time frame
specificity;	—

Secondary

Measure	Time frame
Pathogen distribution;sensitivity;predictive value;Likelihood ratio;Coincidence rate;	—

Countries

China

Contacts

Public ContactLiu Jing

The Third Affliated Hospital of Sun Yat-Sen University

jingliu_1203@hotmail.com+86 13556051920

Outcome results

None listed

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