NCT00502632Unknown2 期
Multicentre Randomized Double-Blinded Trial of Intrapleural Dornase Alfa and Urokinase vs Urokinase Alone for Complicated Parapneumonic Effusions in Children
Azienda Ospedaliera di Padova3 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2007年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 94
- 试验地点
- 3
- 主要终点
- Need for additional surgical procedures
研究概览
简要总结
The purpose of this study is to determine whether intrapleural treatment with Dornase alfa plus Urokinase improves clinical outcome compared to Urokinase alone in children with complicated parapneumonic effusions
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age > 1 year and < 16 years
- •Respiratory infection (pneumonia or lung abscess)
- •Effusion occupying at least 1/3 of hemithorax on chest X-ray
- •Complicated effusion (presence of at least one of the following):
- •Hyperechoic pleural fluid on chest US scan
- •Loculated collection on chest US or CT scan
- •Purulent pleural fluid
- •Positive culture or Gram stain on pleural fluid
排除标准
- •Non parapneumonic effusion
- •Immunodeficiency
- •Neurological impairment
- •Suspected or proven allergy to Urokinase or Dornase alfa
- •Suspected or documented bronchopleural fistula
- •Impaired coagulation (INR>2), haemorrhage, high risk for bleeding
- •Thoracic surgical procedure (e.g. thoracoscopy, mini-thoracotomy) already performed
- •Chest drain inserted since 6 or more days
研究组 & 干预措施
1
Experimental
Intrapleural administration of:
- Urokinase 40,000 in 40ml normal saline, twice daily for 4 days
- Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days
干预措施: Urokinase and Dornase alfa (Drug)
2
Placebo Comparator
Intrapleural administration of:
- Urokinase 40,000 in 40ml normal saline, twice daily for 4 days
- 25ml normal saline, twice daily for 4 days
干预措施: Urokinase (Drug)
结局指标
主要结局
Need for additional surgical procedures
时间窗: 3 months
Duration of hospital stay
时间窗: From beginning of intrapleural treatment
次要结局
- Duration of fever(From beginning of intrapleural treatment)
- Duration of intravenous antibiotic treatment(From beginning of intrapleural treatment)
- Duration of suction applied to chest drain(From beginning of intrapleural treatment)
研究者
研究点 (3)
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