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New test aims to speed up diagnosis of brain infections

NCT ID NCT06820060

Diagnosis Sponsor: QIAGEN Gaithersburg, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study checks how well a new test, the QIAstat-Dx ME Panel Plus, can detect meningitis and encephalitis from spinal fluid samples. Researchers will compare the test results to standard methods using leftover samples from 1500 patients. The goal is to see if the test works accurately in everyday hospital settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with signs and symptoms of Meningitis/Encephalitis infection

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Specimen must be Cerebrospinal fluid, obtained via lumbar puncture only. * Specimen must be a de-identified residual leftover specimen. * Specimen must meet the laboratory testing criteria for individuals with signs and/or symptoms of meningitis and/or encephalitis. * Specimens must have a minimum 450 µL of residual volume. * Specimen must be unique (only one sample enrolled per patient). * Prior to QIAstat-Dx testing, residual CSF specimen must have been stored in accordance with the following: * Prospective Fresh: * Room temperature (15 °C to 25 °C) for ≤24 hrs * Refrigerated (2 °C to 8 °C) for ≤ 7 days * Prospective Frozen: * -15 ºC to -25 ºC for ≤ 2 months * -60 ºC to -90 ºC for ≤ 4 months * Retrospective Archived: * Frozen * At the time of QIAstat-Dx testing, specimen must not have undergone more than three (3) freeze/thaw cycles. * Prospective Samples Only: Specimen must have been collected on or after the date of prospective study activation at the Clinical collection and testing site. * Retrospective Samples Only: Specimens must have a positive diagnosis as per Standard of Care for any of the following viral targets: Herpes simplex virus 1 (HSV-1) Herpes simplex virus 2 (HSV-2) Human herpesvirus 6 (HHV-6) Human parechovirus (HPeV) Varicella zoster virus (VZV) Cytomegalovirus (CMV) Exclusion Criteria: * Residual CSF specimen has been centrifuged. * Residual CSF specimen subject identification or label is unclear or missing. * Residual CSF specimen container has obvious physical damage.

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Conditions

The condition(s) this trial relates to.

encephalitis infectious encephalitis meningitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Encephalitis infection Meningitis

Contacts and locations

Locations

  • QIAGEN

    Manchester, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.