CompletedInterventional

A study to evaluate diagnostic tests used at the point of care for improving antibiotic prescribing for patients with respiratory tract infections in primary care in Europe

Antibiotics are vital medicines for bacterial infections, but using them too often causes bacteria to change and resist treatment. This creates "superbugs" that are hard to treat. Most common coughs and sore throats are caused by viruses, meaning antibiotics will not help them get better. This study, led by the University of Oxford, explores whether quick "point-of-care" tests in GP surgeries can help doctors make better decisions. These tests give fast results during your normal appointment. If you visit your GP with a recent cough or sore throat and your doctor is considering antibiotics, you may be invited to join. Half the participants receive standard care, while the other half have a rapid test to guide their treatment. Researchers track everyone's recovery over 28 days to see if rapid testing safely reduces antibiotic use.

At a glance

Status

Completed

Sponsor

University of Oxford

Enrolment target

2,500

Start

01 Sep 2021

Estimated completion

25 Jan 2024

Community-acquired acute respiratory tract infection

What is this study about?

Antibiotics are life-saving treatments for serious bacterial illnesses like pneumonia. However, when antibiotics are used too often or for the wrong illnesses, bacteria learn how to survive them. This problem is known as antibiotic resistance. Everyday illnesses like sore throats and chesty coughs are among the most common reasons people visit their GP surgery and receive antibiotics, even though viruses—which antibiotics cannot treat—cause the vast majority of these infections.

To help solve this problem, researchers across Europe are testing rapid diagnostic tools known as "point-of-care" tests. These tests can be performed directly inside the doctor's surgery, providing quick answers while you wait. The main goal is to see whether having these test results right away helps doctors safely avoid prescribing antibiotics to patients who do not need them.

Finding better ways to target antibiotics ensures that these vital medicines continue working for future generations. At the same time, the study carefully checks that patients who do not receive antibiotics still recover comfortably and safely, receiving alternative treatments and advice to manage their symptoms.

Key takeaways

Tests whether rapid clinic swabs help GPs prescribe antibiotics more safely.
Open to adults and children aged 1 year and older with a recent cough or sore throat.
Participants are randomly assigned to either normal care or a rapid diagnostic test.
Requires a single clinic appointment, a short 14-day home diary, and a day-28 follow-up call.
Taking part is voluntary and will not change your right to standard NHS healthcare.

Who may be eligible?

You may be able to join this study if you or your child are aged 1 year or older and visit a participating doctor's surgery with a recent respiratory illness. Specifically, you must have either a cough that started less than 28 days ago, or a sore throat that started less than 14 days ago. Your GP must also be considering prescribing an antibiotic for your illness.

You cannot take part if your symptoms only affect your nose or ears (such as an earache or blocked nose on its own), or if you tested positive for COVID-19 within the last 28 days. The study is also not suitable for people with weakened immune systems—such as those on long-term steroid tablets or having cancer treatment—or anyone who needs immediate hospital care.

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 or your child aged 1 year or older?
Do you have a cough that started within the last 28 days, or a sore throat that started within the last 14 days?
Is your GP considering an antibiotic for your symptoms?
Are you free from a positive COVID-19 test in the last 28 days?
Do you have a normal immune system (not taking strong immunosuppressant medicines or steroid tablets long-term)?

Answer every question to see your result.

What does participation involve?

If you agree to take part, your doctor or nurse will first ask you a few questions about your medical history and current illness. If you have been unwell for five days or fewer, you will have a rapid swab for COVID-19. If this test is positive, you will receive standard NHS care and will not continue in the study.

If you continue, a computer will randomly place you into one of two groups. One group receives usual NHS care, where the doctor gives treatment and advice based on standard guidelines. The other group receives a quick test during the appointment—such as a throat swab—and the doctor uses the result to guide your care.

After your appointment, you will complete a brief paper or online diary at home every day for 14 days, which takes about five minutes. The study team will call you around day 14 if you need help with your diary, and again around day 28 to see how you have recovered. In total, your participation lasts about four weeks.

Potential risks and benefits

Taking part may not benefit your health directly, but you will help doctors learn how to treat coughs and sore throats better in the future. The physical risks are very low. If you have a test, taking a sample like a throat swab may feel briefly uncomfortable, and your appointment might take slightly longer than usual. You will still receive full medical attention regardless of your study group. Joining is completely voluntary, and you can leave at any time without your normal NHS care being affected.

Locations (3)

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

NIHR CRN: Thames Valley and South Midlands
Unverified
Oxford, England
Cardiff & Vale University LHB
Unverified
Cardiff, Wales
Cwm Taf Morgannwg University Local Health Board
Unverified
Pontypridd, Wales

Common questions

Will I still be able to get antibiotics if I need them?

Yes. Your doctor will always make the safest treatment choice for you. If your doctor believes you need antibiotics to get better, they will prescribe them.

Can children join the study?

Yes, children aged 1 year and older can take part if their parent or legal guardian gives written permission.

What is a point-of-care test?

It is a medical test done during your appointment that provides results in minutes, rather than having to send samples away to an outside laboratory.

What happens if I start feeling worse at home?

You should seek medical advice just as you normally would, by contacting your GP surgery, calling NHS 111, or visiting an urgent care service.

Does taking part cost anything?

No, taking part is completely free and will not cost you anything.

How to find out more

Emma Harper

emma.harper@phc.ox.ac.uk +44 (0)1865 289 591 Official trial record

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