QIAstat-Dx® Meningitis/Encephalitis Panel Performance Eva... | NCT05155553

Studies
QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study

NCT05155553

Sponsor

QIAGEN Gaithersburg, Inc

Status

Completed

Last Update Posted

Oct 17, 2024Actual

Enrollment

1,524Actual

Phase

Not provided

Conditions

Meningitis/Encephalitis

Interventions

QIAstat-Dx® Meningitis/Encephalitis (ME) Panel

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 4, 2022Actual

Primary Completion Date

Mar 2, 2023Actual

Completion Date

Mar 2, 2023Actual

First Submitted Date

Dec 9, 2021

First Submission Date that Met QC Criteria

Dec 9, 2021

First Posted Date

Dec 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2024

Last Update Posted Date

Oct 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,524Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
QIAstat-Dx® Meningitis/Encephalitis (ME) Panel	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PPA	positive percentage agreement	6 months
NPA	negative percentage agreement	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects (adults and children) with signs and symptoms of meningitis and/or encephalitis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah Johnson	QIAGEN Gaithersburg, Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Qiagen		Manchester			United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

all samples are residual and anonymized

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008581	Meningitis
D004660	Encephalitis

Ancestor Terms

ID	Term
D000090862	Neuroinflammatory Diseases
D009422	Nervous System Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided