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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03895281
Other study ID # SCMC-ME
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2019
Est. completion date April 30, 2020

Study information

Verified date March 2019
Source Shanghai Children's Medical Center
Contact Qing Cao, MD
Phone +86 18930830511
Email caoqing@scmc.com.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 150
Est. completion date April 30, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- 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;

Exclusion Criteria:

- Samples from repeatedly enrolled patients;

- Samples that have not been preserved as required

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
FilmArray Meningitis/Encephalitis (ME) Panel
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Children's Medical Center BioMérieux

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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