Meningitis/EncephalitisNCT03895281
Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel
An observational study of Meningitis/Encephalitis, run by Shanghai Children's Medical Center.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Meningitis/Encephalitis
- What is being tested?
- FilmArray Meningitis/Encephalitis (ME) Panel
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Individuals with signs and/or symptoms of meningitis and/or encephalitis
Who may be able to join
- 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;
Who cannot join
- Samples from repeatedly enrolled patients;
- Samples that have not been preserved as required
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Meningitis/Encephalitis
- Being tested
- FilmArray Meningitis/Encephalitis (ME) Panel
- Medical subject headings
- Meningitis, Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilmArray Meningitis/Encephalitis (ME) PanelDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical sensitivity and specificity of the FilmArray ME Panel
Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay
Measured: 6 days upon sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningitis/EncephalitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Principal investigator, Cao Qing, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895281
- Sponsor's protocol ID
- SCMC-ME
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2019
- Last updated
- 29 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the FilmArray® Meningitis/Encephalitis (ME) Panel
- ClinicalTrials.gov ID
- NCT03895281
- Acronym / sponsor ID
- SCMC-ME
- Conditions
- Meningitis/Encephalitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Individuals with signs and/or symptoms of meningitis and/or encephalitis
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (2 listed)
- Samples from repeatedly enrolled patients;
- Samples that have not been preserved as required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilmArray Meningitis/Encephalitis (ME) PanelThe 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. | Diagnostic test | – |
Primary outcome
Clinical sensitivity and specificity of the FilmArray ME Panel
Time frame: 6 days upon sample collection
Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis/Encephalitis, run by Shanghai Children's Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing Cao, MD (+86 18930830511, caoqing@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical sensitivity and specificity of the FilmArray ME Panel (time frame: 6 days upon sample collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.