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One-Hour brain infection test could save lives

NCT ID NCT06720519

Diagnosis Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new rapid diagnostic panel called QIAstat-Dx that can detect 15 different bacteria, viruses, and fungi causing meningitis and encephalitis in just one hour. Researchers compared its accuracy against standard lab tests using 170 stored spinal fluid samples. If proven reliable, this test could help doctors start the right treatment much sooner, potentially reducing severe brain damage and deaths from these serious infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
QIAstat-Dx Meningitis/Encephalitis Panel (diagnostic test)
What this could lead to
If successful, this test could allow doctors to diagnose meningitis and encephalitis in about one hour instead of days, leading to faster, more targeted treatment and potentially fewer long-term neurological problems.
What could go wrong
This is a completed diagnostic accuracy study, not a treatment trial. The test's real-world impact on patient outcomes has not been directly measured, and it may not be widely available or affordable.

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

170 people

The number who actually took part.

Started

Apr 2024

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Virus or bacterial positive samples from cerebrospinal fluid.

Ages

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

Sex

Anyone

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: * 170 samples of CSF positive for virus and/or bacteria; * Samples stored at -80°C, less than 5 years; * Samples with a volume of at least 800μL. Exclusion Criteria: * Samples of a different matrix than CSF; * Samples stored at room temperature; * Samples for which diagnostic test results are not available; * Samples with a volume of less than 800μL; * Samples already thawed and refrozen.

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease central nervous system infectious disorder encephalitis infectious disorder of the nervous system meningitis viral infectious disease

As listed by the trial registrant

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

Infections nervous system

Contacts and locations

Locations

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, Bologna, 40138, Italy