Randomized Non Inferiority Study Comparing Short Course of Oral Amoxicillin to One of the Usual Treatments of Lower Leg Erysipelas
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o)
研究概览
简要总结
The propose of this study is to determine whether a 6-day duration of oral amoxicillin treatment of erysipelas is non-inferior to a 14-day standard duration intravenous then oral amoxicillin regimen. This trial will be open but evaluation will be perform by a blind evaluator.
详细描述
To fight against increasing rate of bacterial resistance to antibiotics, several studies have demonstrated efficacy of short antibiotic course in e.g. acute streptococcal tonsillitis, community acquired pneumonia, and urinary tract infection. Erysipelas is an acute dermo-hypodermal infection due to streptococcus. To date no resistance of theses bacteria to amoxicillin was described. The diagnosis of erysipelas is clinical. Thus, short course of antibiotic is a good regimen to test in erysipelas treatment. To date there is no controlled trial concerning efficacy of oral amoxicillin in erysipelas treatment. Expected advantages of the demonstration of the non inferiority of a short and oral amoxicillin treatment in erysipelas are: reduction of antibiotic selective pressure, cost, adverse events caused by infusion and hospitalisation.
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
- None
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
- •Males and females ≥ 18 years of age
- •First episode of erysipelas of a lower leg defined as
- •acute well delineate inflammation than had lasted less than 5 days
- •T°≥ 38°5 at least once during the past 5 days or chills.
- •Score ≥3 : oedema, erythema, pain each scored from 0 to 3 : 0= none, 1= moderate, 3= severe
- •Written informed consent provided by the patient
- •available health insurance
- •accept conditions of the trial
排除标准
- •Erysipelas for more than 5 days
- •Score < 3
- •Septic shock
- •Clinical signs of necrotizing cellulitis or fasciitis, bullous lesions related to necrosis, purpuric lesions or superficial cutaneous necrosis.
- •Past history of erysipelas of the same lower leg
- •Erysipelas not on the lower leg
- •Bilateral erysipelas
- •Bite occuring during the preceding 7 days.
- •Diabetic foot
- •patients who have previously received systemic antibiotherapy within the last 5 days (except one or two doses within last 24 hours)
- •History of any hypersensitivity or allergic reaction to beta-lactam drugs
- •Known renal or Hepatic failure
- •Known HIV infection
- •Female patients who are pregnant, lactating (breast milk feeding), or who are of child bearing potential and not using an acceptable method of birth control
- •Impossibility to stop immunosuppressive treatment, systemic corticosteroids or nonsteroidal anti-inflammatory drugs.
- •Severe gastrointestinal disease, dysphagia or any pathology preventing oral administration of treatment.
- •Denied to sign written informed consent
- •Unable or unwilling to adhere to the study-specified procedures and restrictions
- •Evolutive cancer under treatment
研究组 & 干预措施
1:Short treatment
amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day 6 days.
干预措施: Amoxicillin (Drug)
2:Usual treatment
amoxicillin 50 mg/kg/24H ; I.V. ; 3 times/day ; up to apyrexia then amoxicillin ; 50 mg/kg/24H ; P.O. ; 3 times/day up to day 14.
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Clinical cure rate defined as body temperature ≤ 37,5°and disappearance of the cutaneous plaque (score=o)
时间窗: Day 30 ± 5
次要结局
- Time to obtain disappearance of fever and local signs(up to day 30 ± 5)
- Relapse rate(end of treatment to day 30± 5)
- Recurrence rate(day 30± 5 to day 95± 5)
- Frequency of adverse events(30 days ± 5)