Meningitis/EncephalitisNCT05155553
QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study
An observational study of Meningitis/Encephalitis, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
Trial summary
Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meningitis/Encephalitis
- What is being tested?
- QIAstat-Dx® Meningitis/Encephalitis (ME) Panel
- Type of treatment
- Medical device
- How many people
- 1,524 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 May 2022to 2 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects (adults and children) with signs and symptoms of meningitis and/or encephalitis
Who may be able to join
- Residual specimens (minimum 500μL) of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing Specimen that have not undergone more than 3 freeze/thaw cycles.
Who cannot join
- Specimens not fitting criteria outlined above.
- CSF obtained from an external ventricular drain or shunt source.
- Lack of clear subject identification or label on residual banked CSF specimen.
- Specimen has been centrifuged.
- Obvious physical damage of banked residual specimen.
- Repeat specimens from the same subject.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Clinical Performance Evaluation Study Testing Residual Specimens of Cerebrospinal Fluid Obtained by Lumbar Puncture From Meningitis/Encephalitis Subjects Using the QIAstat-Dx® Meningitis/Encephalitis Panel
Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.
Read the detailed description
This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.
- Conditions
- Meningitis/Encephalitis
- Being tested
- QIAstat-Dx® 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.
QIAstat-Dx® Meningitis/Encephalitis (ME) PanelDevice
The performance of QIAstat-Dx® Meningitis/Encephalitis Panel will be evaluated in comparison with another validated comparator method, followed by bidirectional sequencing using residual specimens of cerebrospinal fluid (CSF) obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis.
What is being measured
The primary outcome is the main question the study is designed to answer.
PPA
positive percentage agreement
Measured: 6 months
NPA
negative percentage agreement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start4 May 2022
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,524 participants (actual)
Sponsor and investigators
- Lead sponsor
- QIAGEN Gaithersburg, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Study director, QIAGEN Gaithersburg, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155553
- Sponsor's protocol ID
- SMF-DHF-18-0489-002
- Status last verified
- Oct 2024
- First submitted
- 9 Dec 2021
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all samples are residual and anonymized
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Performance Evaluation Study Testing Residual Specimens of Cerebrospinal Fluid Obtained by Lumbar Puncture From Meningitis/Encephalitis Subjects Using the QIAstat-Dx® Meningitis/Encephalitis Panel
- ClinicalTrials.gov ID
- NCT05155553
- Acronym / sponsor ID
- SMF-DHF-18-0489-002
- Conditions
- Meningitis/Encephalitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,524 participants (actual)
- Lead sponsor
- QIAGEN Gaithersburg, IncIndustry (pharma, biotech, devices)
- Study start
- 4 May 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 13 Dec 2021 (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.
Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.
Detailed description
This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects (adults and children) with signs and symptoms of meningitis and/or encephalitis
Key inclusion criteria (1 listed)
- Residual specimens (minimum 500μL) of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing Specimen that have not undergone more than 3 freeze/thaw cycles.
Key exclusion criteria (6 listed)
- Specimens not fitting criteria outlined above.
- CSF obtained from an external ventricular drain or shunt source.
- Lack of clear subject identification or label on residual banked CSF specimen.
- Specimen has been centrifuged.
- Obvious physical damage of banked residual specimen.
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 |
|---|---|---|
| QIAstat-Dx® Meningitis/Encephalitis (ME) PanelThe performance of QIAstat-Dx® Meningitis/Encephalitis Panel will be evaluated in comparison with another validated comparator method, followed by bidirectional sequencing using residual specimens of cerebrospinal fluid (CSF) obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis. | Device | – |
Primary outcome
PPA
Time frame: 6 months
positive percentage agreement
NPA
Time frame: 6 months
negative percentage agreement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No. all samples are residual and anonymized
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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.
Sarah Johnson study director
QIAGEN Gaithersburg, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningitis/Encephalitis, run by QIAGEN Gaithersburg, Inc at 1 site in United Kingdom.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPA (time frame: 6 months). The study lists 2 primary outcomes in all. 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 17 Oct 2024.