NCT05092438

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
595

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

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

Study Start

First participant enrolled

October 8, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2021

Completed
Last Updated

April 16, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

October 13, 2021

Last Update Submit

April 11, 2025

Conditions

Meningitis/Encephalitis

Outcome Measures

Primary Outcomes (2)

  • sensitivity

    positive percentage agreement

    6 weeks

  • specificity

    negative percentage agreement

    6 weeks

Eligibility Criteria

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

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

You may qualify if:

  • Residual specimens of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing
  • Specimen that had not been centrifuged Adequate residual volume (≥400 μl)

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
  • 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

frozen 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
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2021

First Posted

October 25, 2021

Study Start

October 8, 2021

Primary Completion

December 2, 2021

Study Completion

December 2, 2021

Last Updated

April 16, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

all samples are residual and anonymized

Locations

GB(1)