RecruitingPHASE3INTERVENTIONAL

Cellulitis Optimal Antibiotic Treatment

This study is investigating the best way to treat cellulitis, a common skin infection, especially in the leg. Currently, people often take antibiotics for 7 days. This trial wants to see if a shorter 5-day course of a common antibiotic called flucloxacillin works just as effectively in reducing pain, which is a key concern for patients. It will also look at whether the shorter course is safe and if it could save money for the NHS and patients. Participants will be randomly assigned to either receive the 5-day treatment or the standard 7-day treatment, alongside their usual care, and will share their experiences through daily questionnaires.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Southampton

Enrolment target

334

Start

29 Aug 2023

Estimated completion

01 Jul 2027

Cellulitis of Leg

What is this study about?

Cellulitis is a common and often painful skin infection that usually affects the legs. It can cause swelling, redness, and warmth, and can make you feel generally unwell, affecting your ability to move around and do your normal activities. The good news is that it’s usually treated effectively with antibiotics.

Currently, many people with cellulitis are given a 7-day course of antibiotics to clear up the infection. This study wants to find out if a shorter course of 5 days with the same antibiotic, called flucloxacillin, is just as good at making you feel better and reducing your pain. If a shorter course works just as well, it could mean less time taking medication for patients, and could also be more cost-effective for both you and the NHS.

To find this out, participants in the study will be split into two groups by chance (like flipping a coin). One group will take the antibiotic for 5 days, and the other group will take it for the usual 7 days. Researchers will then compare how effective each treatment is in easing pain and preventing the infection from coming back.

Key takeaways

Compares 5-day vs. 7-day antibiotic treatment for leg cellulitis.
Aims to see if a shorter course is just as effective for pain and recovery.
Uses a common antibiotic called flucloxacillin.
Participants will be randomly assigned to one of the two treatment lengths.
Helpful for guiding future cellulitis treatment in the UK.
You'll share your experiences through daily questionnaires.

Who may be eligible?

This study is looking for adults aged 18 or over who have cellulitis in one leg. You would need to have had symptoms like pain, tenderness, or redness for 10 days or less, and your pain level should be at least a 3 out of 10. You also need to be happy to be chosen at random for either the 5-day or 7-day treatment course and be able to complete some forms in English.

However, some people won't be able to join. For example, if you're allergic to penicillin (which flucloxacillin is related to), or if you have cellulitis in both legs. You also can't participate if you've already had antibiotics for cellulitis in the last month, or if your cellulitis developed after surgery on the same leg within the past month. If your cellulitis is from an animal or human bite, or linked to a very long-lasting (over 6 weeks) leg ulcer, you wouldn't be eligible. Finally, if your cellulitis is so severe that you need to go into hospital or have antibiotics into your vein straight away, this study wouldn't be right for you.

Quick self-check

Are you 18 years old or older?
Do you have cellulitis in only one leg?
Have your cellulitis symptoms been present for 10 days or less?
Is your pain from cellulitis rated 3 out of 10 or higher?
Are you able to complete questionnaires in English?
Are you NOT allergic to penicillin?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have an assessment to check you're suitable. Then, you'll be randomly assigned to one of two groups: either you'll take oral flucloxacillin for 5 days, or for the standard 7 days. Everyone will receive a 5-day supply of the antibiotic. If you're in the 7-day group, you'll also receive two extra tablets, which will either be the antibiotic or a dummy pill (placebo), to continue your treatment for the full 7 days. These extra tablets will be sent to you by post.

Throughout the study, you'll be asked to fill out simple questionnaires once a day. These will help the researchers understand how you're feeling, how your symptoms are progressing, and your overall experience with the treatment and the study itself. The main focus is on your pain levels over days 6 to 14. The total duration of your active participation will involve taking the medication for either 5 or 7 days and then completing questionnaires for a short period afterwards.

Potential risks and benefits

Taking part in this study could offer several potential benefits. You would receive treatment for your cellulitis, and by participating, you might help other people with cellulitis in the future by helping researchers find the most effective and shortest treatment course. There are potential risks associated with any medication, and flucloxacillin can have side effects, which your doctor will discuss with you. There's also a chance the shorter course might not be as effective for you, or that the infection could come back, but this is what the study aims to understand. Importantly, you are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Royal South Hants Hospital
Southampton, United Kingdom· Recruiting

Common questions

What is cellulitis?

Cellulitis is a common bacterial infection of the deeper layers of your skin, often in your leg. It causes redness, swelling, warmth, and pain, and can make you feel unwell.

What is flucloxacillin?

Flucloxacillin is a common antibiotic used to treat bacterial infections like cellulitis.

Why is the study comparing 5 days to 7 days of treatment?

Doctors want to find out if a shorter 5-day course of antibiotics works just as well as the usual 7-day course. If it does, it could be better for patients and the health service.

Will I know if I'm getting the 5-day or 7-day treatment?

You will know you are receiving either a 5-day or 7-day course. For the extended course, you will receive two extra tablets by post that could be active antibiotic or a dummy tablet, so you won't know if you're taking the actual drug on days 6 and 7, but the researchers will keep track.

What if my cellulitis gets worse during the study?

Your health will be monitored, and if your cellulitis worsens or you experience serious side effects, the study team will ensure you receive appropriate medical care, and you can withdraw from the study at any time.

How to find out more

Sophie Varkonyi-Clifford

coat@soton.ac.uk 0 23 8059 1532 Official trial record

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