Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel
1 other identifier
observational
150
0 countries
N/A
Brief Summary
The FilmArray Meningitis/Encephalitis (ME) Panel (hereinafter referred to as FilmArray ME Panel) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems. The FilmArray ME Panel is capable of simultaneous detection and identification of multiple bacterial, viral, and yeast nucleic acids directly from cerebrospinal fluid (CSF) specimens obtained via lumbar puncture from individuals with signs and/or symptoms of meningitis and/or encephalitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2019
CompletedFirst Posted
Study publicly available on registry
March 29, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedMarch 29, 2019
March 1, 2019
9 months
March 28, 2019
March 28, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical sensitivity and specificity of the FilmArray ME Panel
Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay
6 days upon sample collection
Interventions
The FilmArray ME pouch is a closed system disposable that houses all the chemistry required to isolate, amplify and detect nucleic acid from multiple meningitis and encephalitis pathogens within a single CSF specimen obtained from a lumbar puncture. The rigid plastic component (fitment) of the FilmArray ME pouch contains reagents in freeze-dried form. The flexible plastic portion of the pouch is divided into discrete segments (blisters) where the required chemical processes are carried out. The user of the FilmArray ME Panel loads the sample into the FilmArray ME pouch, places the pouch into the FilmArray instrument/Module, and starts the run. All other operations are automated.
Eligibility Criteria
Individuals with signs and/or symptoms of meningitis and/or encephalitis
You may qualify if:
- Residual cerebrospinal fluid samples after routine tests;
- Samples obtained by lumbar puncture;
- Sample volume is not less than 0.5 mL;
- Samples that have not been centrifuged;
You may not qualify if:
- Samples from repeatedly enrolled patients;
- Samples that have not been preserved as required
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Children's Medical Centerlead
- BioMérieuxcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Infectious Diseases
Study Record Dates
First Submitted
March 28, 2019
First Posted
March 29, 2019
Study Start
April 1, 2019
Primary Completion
December 31, 2019
Study Completion
April 30, 2020
Last Updated
March 29, 2019
Record last verified: 2019-03