Comparing Short to Standard Amoxicillin Course for Erysipelas (NCT07104552) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Comparing Short to Standard Amoxicillin Course for Erysipelas
656 participantsStarted 2026-01-01
Plain-language summary
Erysipelas is an acute streptococcal skin infection, primarily affecting the lower limbs and easily diagnosed. In 2000, the French expert consensus conference validated oral amoxicillin at 3 to 4.5 gr per day for 10 to 20 days as a standard treatment, despite the lack of full market approval for erysipelas treatment. In practice, general practitioners (GPs) typically prescribe amoxicillin for around 10 days. In 2019, the Haute Autorité de Santé (HAS), one of the national French Health Authorities, recommended a 7-day antibiotic course for erysipelas, while no RCT was available. Reducing the length of antibiotic courses during acute infections is challenging but necessary to lower therapeutic costs, reduce the risk of bacterial resistance, and improve patient adherence to treatment.
This RCT aims to validate the use of a short course, specifically 5 days, of oral amoxicillin at 50 mg/kg to treat erysipelas, demonstrating its non-inferiority compared to the standard course. The primary objective is to show that a short course (5 days) of amoxicillin at 50 mg/kg is non-inferior to the usual course (10 days) in achieving complete erysipelas remission by day 12 ± 2. The primary end point will be confirmed by a central independent committee, blinded to the intervention received, using photos and clinical data.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients ≥ 18 years
* Affiliated to a social security scheme
* Who have given written consent according to local regulatory requirements after the nature of the study has been explained to them, and prior to any protocol specific procedures being performed,
* Clinical signs of lower limbs erysipelas ≤ 5 days defined as:
o Warmth, erythema, edema (induration of the skin and/or subcutaneous tissue) and/or pain (NRS≤8)
* Shiver, feverish sensation or fever experienced by the patient ≤ 5 days or fever measured by the physician ≥ 38°C
* Severity score ≥ 3 scored on three criteria: edema, erythema, pain with the following scales (0= none, 1=moderate, 2=severe)
* Absence of erysipela ≤ 12 months
* Absence of blisters
* Absence of solid purpura (purple tablecloth not erasing at vitro-pressure)
* Absence of cutaneous necrosis
* Absence of crepitation (crepitation = perception identical to that of cutaneous emphysema
Exclusion Criteria:
* Allergy to ß lactam, fructose intolerance
* Weight \< 40 kg or \> 105 kg
* Use of oral antibiotic within 5 days (excluding one or two antibiotic intake ≤ 24 hours)
* Erysipela/Cellulitis requiring hospitalization
* Bilateral erysipela
* Abscess
* Lymphedema requiring permanent contention
* Animal bite ≤ 7 days
* HIV positive
* Patient with comorbidity: known active hepatitis, chronic kidney failure or hepatocellular insufficiency
* Patient unable to temporarily stop a long-term treatment as antibiotics or corticosteroids, o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of complete remission. Complete remission is a composite outcome defined as
Timeframe: At day 12 +/- 2
2
the disappearance of fever (T°≥ 38°)
Timeframe: At day 12 +/- 2
3
the disappearance of pain
Timeframe: At day 12 +/- 2
4
warmth tenderness erythema at the site of erysipela
Timeframe: At day 12 +/- 2
5
edema at the site of erysipela
Timeframe: At day 12 +/- 2
6
Number of patients who did not receive any additional antibiotics for erysipelas/cellulitis