Comparison of four weeks versus five weeks versus six weeks antibiotic therapy in childhood empyema : An open label randomised controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Clinical worsening in terms of recurrence of fever/respiratory distress/readmission or worsening radiology by x ray or ultrasound requiring any intervention at stopping the antibiotics of prescribed duration that is attributable to empyema.
研究概览
简要总结
Empyema is defined as pus in pleural cavity. There are no Indian guidelines on empyema. There are no studies suggesting optimal duration of antibiotics in empyema in children. SLIM trail that compared short course (14-42 days) versus long course (7-21 days)antibiotic therapy did not find any statistically significant reduction in incidence of treatment failure of empyema in children(16). Hence by comparing 4 weeks vs 5 weeks 6 weeks duration of antibiotic will help in guiding optimal duration of antibiotics in empyema in children. Evidence supporting short course antibiotic therapy will help in reducing cost of treatment on the patient’s perspective, improve compliance and adherence to therapy.
This prospective study is based on hypothesis that 4 weeks of antibiotics may be as effective as 5 or 6 weeks of antibiotics. Study design will be open label placebo controlled randomised control multiple arm trial. Children less than 18 years with empyema will be included and randomised in one of the three groups with different antibiotics duration. The treatment failure will be assesed by requirement of antibiotics beyond the prescribed duration or any additional intervention within 3 months of follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 28.00 Day(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children less than 18 years of age with empyema.
- •Empyema defined as pus in pleural cavity with clinical, laboratory and radiological features suggesting pneumonia or parapneumonic effusion.
排除标准
- •Tubercular Empyema.
- •Empyema secondary to ruptured liver abscess.
- •Empyema secondary to ruptured hydatid cyst.
- •Empyema secondary to Mediastinitis.
- •Empyema secondary to Pancreatitis or Pleuropancreatic Fistula.
结局指标
主要结局
Clinical worsening in terms of recurrence of fever/respiratory distress/readmission or worsening radiology by x ray or ultrasound requiring any intervention at stopping the antibiotics of prescribed duration that is attributable to empyema.
时间窗: time point at baseline, 4 weeks and 3 months.
次要结局
- To document in the incidence of adverse drug effect warranting stoppage of antibiotics or admission during follow up.(Marker of Pulmonary function 3 months after discharge viz Spirometry in children ≥ 6 years old, 6-minute walk test in children 3-6 years old.)
研究者
Ramakrishnan M G
Post Graduate Institute of Medical Education and Research