Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Dermatitis - an Open, Randomized, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 194
- 试验地点
- 2
- 主要终点
- Resolving signs and symptoms of perianal dermatitis
研究概览
简要总结
The goal of the study is to investigate, which of two antibiotic treatments - oral penicillin for 10 days or oral cefuroxim for 7 days - is more successful for patients (1-16 years of age) with perianal dermatitis caused by group A beta-hemolytic streptococci.
详细描述
The goal of the study is to investigate, which of two antibiotic treatments - oral penicillin for 10 days or oral cefuroxim for 7 days - is more successful for patients (1-16 years of age) with perianal dermatitis caused by group A beta-hemolytic streptococci (GABHS). Diagnosis is based on positive perianal culture for GABHS. Informed consent will be obtained.
The study will be performed in the region of Basel, Switzerland, in private practices of pediatricians, general practitioners, and selected pediatric dermatologists as well as in the out-patient departments of the University Children's Hospital Basel and the department for dermatology of the University of Basel.
Patients (or their parents) will fill in a daily diary on signs and symptoms of disease; furthermore, clinical investigations (inspection of the site of infection) will be performed on enrollment (Day 1), Day 3, and at the end of treatment (Day 10).
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
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •age 1-16 years
- •typical clinical symptoms for perianal dermatitis
- •positive perianal culture for GABHS
排除标准
- •antibiotic treatment in previous 14 days
- •immunodeficiency
- •penicillin allergy
- •cephalosporin allergy
- •further bacterial infections
结局指标
主要结局
Resolving signs and symptoms of perianal dermatitis
次要结局
- microbiological cure (= negative culture for GABHS) at end of treatment