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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Pole De Sante Bernard Revel	Vendargues	France
Mivielle Claire	Sallanches	France
Pinto Bruno	Le Plessis-Belleville	France
Yvart Laurine	Garches	France
Msp De Corbie	Corbie	France
Brahimi Melina	Chevry Cossigny	France
Msp De Chambly	Chambly	France
Mont Royal Sante SISA	Montrejeau	France
Bourlier Pierre-Vincent	Pontcharra	France
Tranchant Loic	Messimy	France
MSP Terre De Flandre	Hazebrouck	France
Maison de santé pluriprofessionnelle universitaire Jacques Prévert	Montigny le Bretonneux	France
Cabinet Médical les Oiseaux	Morsang-sur-Orge	France
Maison de Santé Pluridisciplinaire de Torcy	Torcy	France
MSP Du Confluent	Conflans Sainte Honorine	France
Rousselot Nicolas	Bordeaux	France

Other Sites

Site Name	City	Country
Sopudas Surqorps	Le Havre	France
Cbhsahh Mxpdxsf Dv Tqeyl Skrpaj	Paris	France
Dv Cqpiqmx Mmpexku Dx Mkapmc Sdtbpc	Merlimont	France
Clrcyanlfj Mpjb Sypllre Mqlmru	Oullins-Pierre-Bénite	France
R I P E M A	Wattrelos	France
Fworl Btcclpyf	Saint-Georges-D'Orques	France
Jetdbxya Mkrdxq	Annecy	France
Cqoldjx Dh Vmzyspsky	Villejuif	France
Crukubf db Mqrmastk Gqysqpgs dg Lvnn	Leyr	France
Myqqvv mqkbpgpm	Le Grand Quevilly	France
Mamasg dt Sgutt Pekoyzaiwzgrtlrgvo dy Mesrqivu	Mauvezin	France
Csvyliv Mftncvb dg Dw Madukc	Pontgibaud	France
Mjmcdz dw Sjwwl Lo Caaosypoba	Poissy	France
Mqbqkn ds Sinuh Pjefalhmiytfnbsyno Cfflqqfus Crlspy	Chateau Thierry	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	28.01.2025

Trial locations

Investigated drugs:

Amoxicillin Sodium

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.

Investigated diseases:

Pyoderma

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 ID:

2024-515306-61-00

Protocol code:

P150924

NCT ID:

NCT07104552

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?