Comparing Short to Standard Amoxicillin Course for Erysipelas: a Non-inferiority Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 656
- 主要终点
- Rate of complete remission. Complete remission is a composite outcome defined as
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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, or NSAIDs
- •Patient under immunosuppressive or oncologic treatments ≤ 6 months
- •Pregnant women or breastfeeding
- •Patient under guardianship or curatorship, legal protection or protection of justice
- •Participation in other Clinical Trial, interventional study, investigational study or performance study Any medical, mental, psychological or psychiatric condition considered by the investigator as compromising patient completion or understanding of the study
研究组 & 干预措施
Amox5Days
Amoxicillin 50 mg/kg for five days
干预措施: Course of amoxicillin (Drug)
Amox10Days
Amoxicillin 50 mg/kg for ten days
干预措施: Course of amoxicillin (Drug)
结局指标
主要结局
Rate of complete remission. Complete remission is a composite outcome defined as
时间窗: At day 12 +/- 2
1. 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; and 2. the absence of additional antibiotherapy for the initial condition, i.e., erysipelas/cellulitis. The clinical severity score corresponds to the addition of the 3 score value of pain, warmth tenderness erythema and edema.
Number of patients who did not receive any additional antibiotics for erysipelas/cellulitis
时间窗: At day 12 +/- 2
absence of additional antibiotherapy for erysipelas/cellulitis
the disappearance of fever (T°≥ 38°)
时间窗: At day 12 +/- 2
T\<38°
the disappearance of pain
时间窗: At day 12 +/- 2
the pain is measured from the numerical assessment (EN). The score is graded according to the following EN values: * if EN = 0, this equates to score 0 (Absent) * If EN between 1 and 8, this corresponds to a score of 1 (Moderate) * IF IN \> 8, this corresponds to a score of 2 (Severe)
edema at the site of erysipela
时间窗: At day 12 +/- 2
It is graded according to the following values: * if absent, this equates to score 0 * If moderate, this corresponds to a score of 1 * If severe, this corresponds to a score of 2
warmth tenderness erythema at the site of erysipela
时间窗: At day 12 +/- 2
It is graded according to the following values: * if absent, this equates to score 0 * If moderate, this corresponds to a score of 1 * if severe, this corresponds to a score of 2
次要结局
- 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(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)