AuthorisedTherapeutic use (Phase IV)Interventional

Comparing short to standard amoxicillin course for eRysipElas: a non-inferiority randomized controlled trial .SHARE II

This research, called "SHARE II," is comparing two different lengths of amoxicillin treatment for adults who have a skin infection known as erysipelas, specifically on their lower legs. Erysipelas can cause redness, swelling, and pain. The main goal is to find out if a shorter course of amoxicillin (an antibiotic) is just as effective as the standard, longer course. This means checking if patients recover fully around 12 days after starting treatment, without needing more medication for their infection. The study aims to see if we can use less medicine while still getting the same good results, which could be better for patients.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

656

Start

26 Nov 2024

Adults diagnosed with lower limbs erysipelas

What is this study about?

Imagine you have a skin infection on your leg, like erysipelas, which can make your skin red, swollen, and painful. Doctors usually treat this with an antibiotic called amoxicillin for a certain period. This study, called SHARE II, is looking into whether a shorter course of this antibiotic works just as well as the standard, longer course. We want to see if people get completely better with less medication. This is important because using antibiotics for a shorter time can sometimes reduce side effects and help prevent antibiotic resistance, where germs become harder to treat.

To figure this out, some patients will receive the standard course of amoxicillin, while others will receive a shorter course. The doctors will then carefully check around 12 days after treatment starts to see if the infection has completely cleared up. 'Completely cleared up' means things like fever, pain, and swelling are gone, and the skin looks much better, without needing any extra antibiotics for the infection.

They will also look at how many people need more antibiotics later on, if anyone gets the infection again, and if people experience any side effects from the medication. The aim is to find the best way to treat erysipelas, making sure patients recover fully while using medication safely and effectively.

Key takeaways

This study is comparing short vs. standard antibiotic treatment for erysipelas.
It aims to find out if less amoxicillin can be just as effective.
Adults with erysipelas on their lower legs can participate.
The main goal is to see if symptoms fully clear up by day 12.
Side effects and long-term recurrence will also be monitored.

Who may be eligible?

This study is for adults who have been diagnosed with erysipelas, which is a type of skin infection, specifically on their lower legs. Both men and women can take part.

There isn't an upper age limit, so as long as you're over 18 and have this specific condition, you might be able to join. Your doctor will need to confirm your diagnosis and make sure it's safe for you to take part 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.

Are you 18 years old or older?
Have you been diagnosed with erysipelas?
Is your erysipelas on your lower limbs (legs)?
Are you able to follow the study schedule and take the medication as directed?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given amoxicillin, an antibiotic for your erysipelas, for either a short or standard length of time. You won't know which length you're getting, as this helps make the study fair. You'll likely have a few appointments with the study team. They will check your symptoms, like your temperature, pain, and how your skin looks at the site of the infection, to see how well the treatment is working. This will happen around 7 and 12 days after you start treatment. They will also look out for any side effects you might experience. There will be at least one follow-up check around 28 days after starting treatment to see if the infection comes back or if you needed any more antibiotics. The total duration of active follow-up for this study is approximately one month.

Potential risks and benefits

Participating in this study might offer the benefit of potentially finding a more efficient way to treat erysipelas, or you might find that a shorter course of antibiotics works for you. All medical treatments carry some risks; with amoxicillin, these can include common side effects like upset stomach or allergic reactions, though serious side effects are rare. The study team will monitor you closely for any issues. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is erysipelas?

Erysipelas is a type of bacterial skin infection, often causing red, swollen, and painful areas on the skin, commonly on the legs.

What is amoxicillin?

Amoxicillin is a common antibiotic medication used to treat a variety of bacterial infections.

Why are you studying a shorter course of treatment?

We want to see if patients can get better just as effectively with less medicine, which could mean fewer side effects and help prevent antibiotic resistance in the long run.

Will I know if I'm getting the short or standard course?

No, to ensure fair results, you won't know which length of treatment you are receiving until after the study is complete.

What does 'complete remission' mean in this study?

It means your fever, pain, warmth, redness, and swelling from the infection have gone away, and you haven't needed any additional antibiotics for your erysipelas.