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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515306-61-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amox5Days | Experimental | Amoxicillin 50 mg/kg for five days |
|
| Amox10Days | Active Comparator | Amoxicillin 50 mg/kg for ten days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Course of amoxicillin | Drug | Oral amoxicillin per os at 50 mg/kg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of complete remission. Complete remission is a composite outcome defined as |
The clinical severity score corresponds to the addition of the 3 score value of pain, warmth tenderness erythema and edema. | At day 12 +/- 2 |
| the disappearance of fever (T°≥ 38°) | T<38° | At day 12 +/- 2 |
| the disappearance of pain | the pain is measured from the numerical assessment (EN). The score is graded according to the following EN values:
| At day 12 +/- 2 |
| warmth tenderness erythema at the site of erysipela | It is graded according to the following values:
| At day 12 +/- 2 |
| edema at the site of erysipela | It is graded according to the following values:
| At day 12 +/- 2 |
| Number of patients who did not receive any additional antibiotics for erysipelas/cellulitis |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of clinical remission: the disappearance of fever (T°≥38°) AND of pain, warmth tenderness erythema and edema at the site of erysipelas and for the cutaneous plaque a clinical severity score less than or equal to 1 at day 12+/- 2 | At day 12 +/- 2 | |
| Rate and number of patients not receiving additional antibiotherapy at day 12+/- 2 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tu-Anh Duong, PhD | Contact | + 33 1 49 09 44 29 | tu-anh.duong@aphp.fr | |
| Olivier Chosidow, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| France Guyot | Assistance Publique Hôpitaux de Paris - DRCI | Study Chair |
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| ID | Term |
|---|---|
| D004886 | Erysipelas |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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absence of additional antibiotherapy for erysipelas/cellulitis
| At day 12 +/- 2 |
| at day 12+/- 2 |
| Rate of recurrence is defined by the need for additional antibiotic therapy for cellulitis between day 12 and day 28+/- 2. | at day 12 and day 28+/- 2 |
| Rate of adverse event during the treatment and the follow up periods as reported by the patient | at day 12+/- 2 |
| Rate of clinical remission: disappearance of fever (≥38) AND pain, warmth tenderness erythema and edema at the site of erysipelas and for the cutaneous plaque a clinical severity score less than or equal to 1, without receiving additional antibiotherapy | at day 7 +/- 2 |
| D007239 | Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |