RecruitingNot ApplicableObservational

Performance of host response tests in acute respiratory infection

Doctors often struggle to tell if breathing problems are due to a virus or bacteria, so they frequently prescribe antibiotics just in case. However, antibiotics don't work on viruses and overuse can lead to them becoming less effective in the future. This study wants to check if some new, quick tests can accurately tell the difference between viral and bacterial infections right when a patient arrives at the hospital. These 'point-of-care' tests could help doctors make better treatment decisions, meaning fewer unnecessary antibiotics are used. By taking part, you'd be helping to find out if these tests genuinely work, which could improve care for many patients in the future.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

500

Start

10 Feb 2025

Estimated completion

10 Jan 2028

Comparing diagnostic accuracy of different host response tests in acute respiratory illness in adults

What is this study about?

When you come to the hospital with a cough or breathing difficulties, it can be tricky for doctors to figure out if a virus or bacteria is causing your illness. Viruses, like the common cold or flu, don't respond to antibiotics. However, because it's so hard to tell the difference quickly, doctors often prescribe antibiotics "just in case" it's a bacterial infection.

Giving out antibiotics when they're not needed can cause problems. It might mean some people experience side effects from the medication for no good reason. More importantly, it contributes to 'antibiotic resistance' – this is when bacteria learn to fight off antibiotics, making these important medicines less effective over time. This is a big worry for everyone's future health.

This study is testing some exciting new tools called 'host response tests'. These tests look at how your body's immune system reacts to an infection and can potentially tell a bacterial infection apart from a viral one. Some of these tests are very fast, meaning they could be used right in the emergency room. We want to see if these new tests are accurate and if they can really help doctors choose the right treatment for patients, reducing the number of unnecessary antibiotic prescriptions.

Key takeaways

This study aims to find better ways to diagnose breathing infections.
It tests new, quick tools to tell if an infection is viral or bacterial.
Participation involves extra blood tests and nose/throat swabs.
Your immediate medical care will not be affected by study results.
You won't get personal results, but your contribution helps future patient care.
Risks are minimal, similar to routine hospital procedures.

Who may be eligible?

This study is looking for adults aged 18 or over who come to the Emergency Department (ED) or Acute Medical Unit (AMU) at University Hospital Southampton. You would need to have symptoms of a recent breathing problem, such as a cough, shortness of breath, a sore throat, 'the sniffles', wheezing, or a fever, that started within 24 hours of your arrival.

To join, you must be able to understand the study and agree to take part yourself. The study will not include people who have certain long-term lung conditions like severe bronchiectasis or cystic fibrosis, or those with very weak immune systems. If you're not comfortable with blood tests or having a swab taken from your nose or throat, then this study might not be for you.

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.

Are you 18 years old or older?
Are you currently at University Hospital Southampton's ED or AMU?
Do you have a new cough, breathing issues, sore throat, or fever?
Did your symptoms start in the last 24 hours?
Are you able to understand and agree to take part?
Do you not have a severe long-term lung condition or a very weak immune system?

Answer every question to see your result.

What does participation involve?

If you agree to take part, the research team will ask for some extra blood samples at the same time as any blood tests you're already having for your regular care. We’ll also ask for three swabs from your nose and throat, and two small blood samples from a finger-prick. Most of these extra tests will be done at your bedside.

Important to know: the results of these new tests won't be shared with you or your doctors while you're in the hospital. This is because we are still testing how well they work, so your medical care won't change based on these specific study tests. Your doctors will continue to treat you as they normally would. The study period will involve these initial tests while you are in the ED or AMU.

Potential risks and benefits

You won't directly benefit from taking part in this study because the results of the new tests won't be used to guide your immediate treatment. However, many people find it rewarding to know they are helping to improve how the NHS cares for patients with breathing problems in the future. The risks of participating are very low and similar to what you might experience during standard hospital care. The finger-prick blood tests and nose/throat swabs might cause a little discomfort or feel strange for a short time, but serious problems are not expected. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

University Hospital Southampton
City only
Southampton, England

Common questions

Why can't I know the results of my study tests?

Because these tests are brand new and still being researched, we don't know for sure how accurate they are yet. Sharing the results wouldn't help your immediate treatment. This study is all about checking their accuracy first.

Will taking part in the study change my treatment?

No, your treatment will not change. Your doctors will continue to treat you based on their usual assessments and standard tests, just as they would if you weren't in the study.

How long will I be involved in the study?

Your involvement in the study will be focused on the samples taken during your time in the Emergency Department or Acute Medical Unit. There are no follow-up visits specifically for the study.

What happens to my samples after the study?

Your samples will be used to test the new diagnostic devices and help researchers understand more about breathing infections. All samples will be handled with strict privacy.

Can I leave the study once I've joined?

Yes, you can choose to leave the study at any time without giving a reason. Your decision will not affect your medical care.

How to find out more

Alex Tanner

A.Tanner@soton.ac.uk +44 (0)7946 715043 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.