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New rapid test could speed up UTI diagnosis and antibiotic choice

NCT ID NCT06824129

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study evaluates a new test called the QIAstat-Dx cUTI Plus AMR Panel, which aims to quickly detect bacteria and antibiotic resistance in urine samples from people with suspected complicated urinary tract infections (cUTI). Researchers will enroll 1500 participants of all ages to see how well the test works compared to standard lab methods. If accurate, this test could help doctors choose the right antibiotic faster, but it is still being tested and is not yet proven to improve patient care.

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 cUTI Plus AMR Panel (diagnostic test)
What this could lead to
If successful, this test could help doctors quickly identify the right antibiotic for complicated UTIs, potentially improving treatment and reducing antibiotic misuse.
What could go wrong
This is a performance evaluation, not a treatment trial. The test may not be more accurate than current methods, and results may not change patient outcomes.

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

Dec 2025

Expected to finish

Sep 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 complicated urine 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: * Specimens from subjects of all ages and demographic characteristics can be enrolled. * Specimen must come from patients with suspected cUTI by their healthcare provider: * Urine specimen with evidence of pyuria confirmed by positive urine analysis (Dipstick analysis positive for leukocyte esterase or at least 10 White Blood Cells percubic millimeter) And * A sign or symptom of a cUTI (for example: chills or rigors or warmth associated with fever, malaise, flank pain or pelvic pain and/or costo-vertebral angle pain or tenderness on physical examination, nausea or vomiting, dysuria, urinary frequency or urinary urgency) * Specimen must be residual leftover and de-identified * Specimen obtained preserved (containing boric acid, sodium formate or sodium borate) or unpreserved as midstream urine or fresh urine catheter * For Preserved Only: Fresh prospectively collected preserved specimens stored to up 48 hours at 15°C-25°C or 24 hours at 2°C-8°C. * For Unpreserved Only: Fresh prospectively collected unpreserved specimens stored up to 24 hours at 2°C-8°C. * Specimen must have a minimum of 3 ml of urine available. * Specimen date of collection and standard of Care testing results should be available. * Specimen must be unique (only one sample enrolled per patient). Exclusion Criteria: * Specimens enrolled in the study may be excluded for the following reasons: * Lack of clear subject identification or label on urine specimen. * Specimen has been centrifuged. * Obvious physical damage of residual specimen.

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Conditions

The condition(s) this trial relates to.

bacterial urinary tract infection

As listed by the trial registrant

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

Complicated urinary tract infection

Contacts and locations

Locations

  • QIAGEN

    Manchester, United Kingdom

More trials for these conditions

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