Active not recruitingOBSERVATIONAL

Clinical Performance Evaluation of the QIAstat-Dx® cUTI Plus AMR

This study is evaluating a new medical device called the QIAstat-Dx cUTI Plus AMR Panel. This device is designed to rapidly detect the types of bacteria causing complicated urinary tract infections (cUTIs) and to identify if these bacteria are resistant to antibiotics. The main goal is to confirm that this new device works as it should when used by healthcare professionals in a real-world setting. Researchers will compare its results with those from existing, established methods to ensure accuracy. Another important aspect of the study is to check that the device is safe for the healthcare staff who will be operating it. By doing this, the study aims to ensure that the QIAstat-Dx is a reliable and safe tool for diagnosing complicated urine infections.

At a glance

Status

Active not recruiting

Sponsor

QIAGEN Gaithersburg, Inc

Enrolment target

1,500

Start

23 Dec 2025

Estimated completion

01 Sep 2026

Complicated Urinary Tract Infection

What is this study about?

This study is all about making sure a new piece of medical equipment, called the QIAstat-Dx, works correctly and safely. This device is specifically designed to help doctors quickly find out what kind of germs are causing complicated urine infections (cUTIs) and, importantly, whether those germs are resistant to common antibiotics. This information is really important because it helps doctors choose the right treatment for patients much faster.

Imagine you have a urine infection, and it's a bit more serious than usual (a 'complicated' one). Normally, it can take a day or two to get the specific lab results back about which germ is causing it and which antibiotics will work. This new device aims to speed that up significantly. By getting this information quickly, doctors can start you on the most effective antibiotics sooner, which can lead to a quicker recovery and could help reduce the spread of antibiotic-resistant bugs.

The researchers are testing this device to confirm its accuracy by comparing its findings with the standard lab tests currently used. They're also making sure that it's easy and safe for healthcare staff to use. This kind of careful testing is a crucial step before any new medical device can be widely used in places like GP surgeries and hospitals across the UK.

Key takeaways

Testing a new device for complicated urine infections (cUTIs).
Aims to quickly identify germs and antibiotic resistance.
Uses leftover, anonymised urine samples from routine care.
No extra procedures, visits, or medication for participants.
Helps improve future diagnosis and treatment for cUTIs.
Ensures the new device is effective and safe for healthcare staff.

Who may be eligible?

You might be able to help with this study if you are a patient of any age who has a complicated urinary tract infection (cUTI). This means your doctor suspects you have a cUTI, and you have certain symptoms like chills, fever, malaise, flank or pelvic pain, sickness, or pain or urgency while peeing. Crucially, a urine test must also show signs of infection, such as white blood cells in your urine.

To be included, the researchers will use a leftover urine sample that you’ve already provided for your normal care, meaning you won't need to give an extra sample just for the study. This sample must be of a certain amount and collected in a specific way.

However, you wouldn't be able to take part if your urine sample isn't clearly labelled, has been spun down in a machine, or if the container is obviously damaged. Also, only one sample per patient will be included in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a suspected complicated urine infection (cUTI)?
Did your doctor's urine test show signs of infection, like white blood cells?
Do you have cUTI symptoms, such as fever, flank pain, or painful urination?
Is there a leftover urine sample from your routine care that can be used?
Was your urine sample collected in a standard way (midstream or catheter sample)?

Answer every question to see your result.

What does participation involve?

Taking part in this study is very straightforward because it doesn't involve any extra visits, tests, or medication for you. The researchers will simply use a leftover part of a urine sample you've already given as part of your routine medical care for your complicated urinary tract infection. This leftover sample will have had all your personal details removed, so it can't be traced back to you.

Because no additional procedures are needed, there's no follow-up specifically for the study, and your overall involvement is limited to that single, de-identified urine sample.

Potential risks and benefits

There are no direct benefits or risks to you for taking part in this study because it uses a leftover, anonymous urine sample from your routine care. You won't undergo any extra procedures, so there's no impact on your health or treatment. The main benefit is that your contribution helps evaluate a new diagnostic tool that could lead to faster and more accurate treatment decisions for people with complicated urine infections in the future. As your involvement is through an anonymised, leftover sample, the concept of withdrawing from the study in the usual sense isn't applicable.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

QIAGEN
Verified postcode
Manchester, United Kingdom

Common questions

What is a 'complicated' urinary tract infection (cUTI)?

It's a urine infection that's considered more serious or challenging to treat, often due to underlying health conditions or certain symptoms like fever or severe pain.

What is the QIAstat-Dx device?

It's a new machine being tested that can quickly identify the germs causing urine infections and check if they are resistant to antibiotics.

Will I have to do anything extra if I'm in this study?

No, you won't need to do anything. The study only uses a leftover part of a urine sample you've already given for your normal medical care, with your details removed.

How will my privacy be protected?

Your urine sample will be 'de-identified,' meaning all your personal information is removed so it can't be linked back to you and your privacy is maintained.

Why is this study important?

It helps make sure new medical tools work well and safely, which could lead to quicker and more effective treatments for urine infections for everyone in the future.