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Study on Short vs. Standard Amoxicillin Treatment for Adults with Lower Limb Erysipelas

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of erysipelas, a skin infection that often affects the lower legs. The study will use a medication called amoxicillin, which is a type of antibiotic known as semi-synthetic penicillin. The purpose of the study is to determine if a shorter course of amoxicillin treatment, lasting 5 days, is as effective as the standard 10-day course in achieving complete recovery from erysipelas.

Participants in the study will be randomly assigned to receive either the short or standard course of amoxicillin. The treatment will be taken orally, meaning it is swallowed in pill form. The study will monitor the participants' recovery over a period of time, checking for the disappearance of symptoms such as fever, pain, warmth, redness, and swelling at the site of the infection. The goal is to see if the shorter treatment is just as good at helping patients recover without needing additional antibiotics.

The study will also look at other factors, such as the rate of recurrence of the infection and any side effects experienced by participants during and after the treatment. This information will help determine the best treatment duration for erysipelas, potentially leading to shorter and more convenient treatment options for patients in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, absence of certain skin conditions, and recent symptoms of erysipelas.

    Written consent is required after the study details are explained.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the severity of erysipelas, including symptoms like warmth, redness, swelling, and pain.

    A severity score is assigned based on these symptoms.

  3. Step 3

    Treatment phase

    The treatment involves taking amoxicillin orally. The dosage is 50 mg per kilogram of body weight.

    The treatment duration is either a short course of 5 days or a standard course of 10 days, depending on the group assignment.

  4. Step 4

    Monitoring and follow-up

    Symptoms are monitored to assess the disappearance of fever, pain, warmth, redness, and swelling.

    The primary goal is complete remission by day 12, which includes no need for additional antibiotics.

  5. Step 5

    Final evaluation

    A final evaluation is conducted to confirm the absence of symptoms and the need for further treatment.

    The rate of recurrence and any adverse events are also recorded during this period.

Who can join the trial?

11 criteria

  • Must be an adult, aged 18 years or older.
  • Must not have any skin tissue death, known as **cutaneous necrosis**.
  • Must not have any crackling sensation under the skin, known as **crepitations**.
  • Must be part of a social security program.
  • Must have given written consent to participate after understanding the study details.
  • Must have signs of leg **erysipelas** for 5 days or less, which include warmth, redness, swelling, and/or pain.
  • Must have experienced chills, a feverish feeling, or a fever for 5 days or less, or have a fever of 38°C or higher measured by a doctor.
  • Must have a severity score of 3 or more, based on swelling, redness, and pain, rated as none, moderate, or severe.
  • Must not have had **erysipelas** in the last 12 months.
  • Must not have any blisters.
  • Must not have any solid purple spots on the skin that do not fade when pressed, known as **solid purpura**.

Who cannot join the trial?

3 criteria

  • Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
  • Patients who do not have a diagnosis of erysipelas in the lower limbs cannot participate. Erysipelas is a skin infection that causes redness and swelling.
  • Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like pregnant women, children, or those unable to give consent.
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Investigated drugs

Amoxicillin is an antibiotic used to treat bacterial infections. In this clinical trial, it is being tested to see if a shorter course of treatment is as effective as the standard longer course for treating erysipelas, a type of skin infection. The trial aims to determine if taking amoxicillin for 5 days is just as good as taking it for 10 days in achieving complete remission of the infection.

What is already known about the treatment

Amoxicillin – Amoxicillin is administered orally, typically in the form of tablets or capsules. It is currently well-established in medical practice and literature as a widely used antibiotic. The main therapeutic indication for amoxicillin in this trial is the treatment of erysipelas, a bacterial skin infection affecting the lower limbs. At the molecular level, amoxicillin works by inhibiting the synthesis of bacterial cell walls, leading to the destruction of the bacteria. It is classified pharmacologically as a penicillin-type antibiotic.

Investigated diseases

Erysipelas – Erysipelas is a bacterial skin infection that typically affects the upper layers of the skin. It is characterized by a bright red, swollen, and warm area on the skin, often with a distinct raised border. The infection usually occurs on the legs but can also appear on the face or other parts of the body. Symptoms may include fever, chills, and a general feeling of being unwell. The condition progresses as the affected area becomes more inflamed and painful. If left untreated, the infection can spread to other areas of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515306-61-00Protocol codeP150924Estimated enrolment656 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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