Impact of Antibiotic Treatment of Group A Streptococcal Blistering Distal Dactylitis in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Camille JUNG
- 入组人数
- 177
- 试验地点
- 2
- 主要终点
- Rate healed blistering distal dactylitis with positive GAS test after 10 days of antibiotherapy directed against streptococcus pyogenes
研究概览
简要总结
Single-center prospective study to assess the clinical course of group A streptococcal blistering distal dactylitis in children after antibiotic treatment.
详细描述
Blistering distal dactylitis are very common in children. About 60% are caused by Staphylococcus aureus and some are caused by Group A Streptococcus (GAS) or Streptococcus pyogenes. While these forms have been known for fifty years, few publications are interested in it. Some studies have confirmed that a single antibiotic treatment against the SGA allows the healing of these dactylitis but few surgical teams have adopted this strategy. As all streptococcal infections, they face the risk of acute complications (septicemia, streptococcal toxic shock, etc.) or late (post-streptococcal glomerulonephritis, acute rheumatic fever, etc.). The involvement of the SGA in these dactylitis is easy to demonstrate through the use of rapid GAS test already widely used in other GAS infections (tonsillitis, scarlet fever, streptococcal perianal infections).
This study aims to assess the clinical course of positive GAS test blistering distal dactylitis in children after antibiotic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 0-18 years
- •Distal blistering dactylitis collected or not collected
- •Positive rapid Group A Streptococcus test
- •Informed consent signed by the parents
排除标准
- •Subungual or pulp Whitlow
- •Children not affiliated to the social security scheme
- •Refusal by the parents to participate in the study
研究组 & 干预措施
Positive rapid Group A Streptococcus (GAS) test
In case of positive rapid GAS test, patients will be treated by antibiotics: amoxicillin 50mg/kg/d during 10 days or cefpodoxime 8mg/kg/d during 10 days in case of betalactamine allergy
干预措施: Positive rapid GAS test (Procedure)
Negative rapid GAS test
If case of negative rapid GAS test, usual care: local antiseptic or surgical intervention
干预措施: Negative rapid GAS test (Procedure)
结局指标
主要结局
Rate healed blistering distal dactylitis with positive GAS test after 10 days of antibiotherapy directed against streptococcus pyogenes
时间窗: 10 days
The main objective of this study is to evaluate the effectiveness of antibiotic treatment only if paronychia subungual child collected or not collected with a in distal blistering dactylitis with positive GAS test
次要结局
- Frequency of collected distal blistering dactylitis with positive GAS test in children(18 months)
- Frequency of germs involved in distal blistering dactylitis after pus culture in children(18 months)
- Sensitivity of GAS test compared to pus culture(18 months)
- Frequency of distal blistering dactylitis with positive GAS test in children(18 months)
- Specificity of GAS test compared to pus culture(18 months)
- Correlation between GAS test and pus culture in different age groups(18 months)
- Number of General anesthesia avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis(18 months)
- Number of surgical procedures avoided by use of antibiotics treatment instead of surgical procedure in case of collected distal blistering dactylitis(18 months)
- Comparison between the cost of antibiotics versus surgical or local treatments of positive GAS test distal blistering dactylitis in children(18 months)
- Rate of healed collected distal blistering dactylitis with positive GAS test after antibiotic treatment(18 months)
- Number of Nail dystrophy at 3 months of follow-up(3 months)
研究者
Camille JUNG
MD PhD
Centre Hospitalier Intercommunal Creteil