2024-515306-61-00招募中4 期
Comparing short to standard amoxicillin course for eRysipElas: a non-inferiority randomized controlled trial .SHARE II
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 656
- 试验地点
- 35
- 主要终点
- Rate of complete remission at day 12+/- 2. Complete remission is a composite outcome defined as 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 cellulitis.
研究概览
简要总结
To demonstrate that a short course (5 days) of amoxicillin 50 mg/kg is not inferior to the usual course (10 days) to achieve complete erysipelas remission at day 12+/-2 confirmed by a central independent committee blinded adjudicated from the intervention received, using photos and clinical datas.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years
- •Absence of cutaneous necrosis
- •Absence of crepitations (crepitation = perception identical to that of cutaneous emphysema
- •Affiliated to a social security scheme
- •Who, after the nature of the study has been explained to them, and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements
- •Clinical signs of leg erysipelas ≤ 5 days defined by the association of : 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 erysipelas ≤ 12 mois
- •Absence of blisters
- •Absence of solid purpura (purple tablecloth not erasing at vitro-pressure)
排除标准
- •Allergy to ß lactam, intolerance to fructose
- •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
- •Anti-cancer, immunotherapy or immunosuppressive therapy ≤ 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
- •Weight < 40 kg or > 105 kg
- •Use of oral antibiotic within 5 days (excluding one or two antibiotic intake ≤ 24 hours)
- •Dermohypodermitis requiring hospitalization
- •Erysipelas bilateral
- •Lymphedema requiring permanent contention
- •Animal bite ≤ 7 days
- •HIV positive
结局指标
主要结局
Rate of complete remission at day 12+/- 2. Complete remission is a composite outcome defined as 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 cellulitis.
Rate of complete remission at day 12+/- 2. Complete remission is a composite outcome defined as 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 cellulitis.
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.
- Rate and number of patients not receiving additional antibiotherapy 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.
- Rate of adverse event during the treatment and the follow up periods as reported by the patient.
- 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, without receiving additional antibiotherapy at day 7 +/- 2
研究者
Tu Anh Duong
Scientific
Assistance Publique Hopitaux De Paris
研究点 (35)
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