NCT05155553

Brief Summary

Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,524

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

May 4, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
Last Updated

October 17, 2024

Status Verified

October 1, 2024

Enrollment Period

10 months

First QC Date

December 9, 2021

Last Update Submit

October 15, 2024

Conditions

Meningitis/Encephalitis

Outcome Measures

Primary Outcomes (2)

  • PPA

    positive percentage agreement

    6 months

  • NPA

    negative percentage agreement

    6 months

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qiagen

Manchester, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

residual specimens of CSF obtained by lumbar puncture

MeSH Terms

Conditions

MeningitisEncephalitis

Condition Hierarchy (Ancestors)

Neuroinflammatory DiseasesNervous System DiseasesBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Sarah Johnson

    QIAGEN Gaithersburg, Inc

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

December 13, 2021

Study Start

May 4, 2022

Primary Completion

March 2, 2023

Study Completion

March 2, 2023

Last Updated

October 17, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

all samples are residual and anonymized

Locations

GB(1)