Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 6
- 主要终点
- Time to Hospital Discharge
研究概览
简要总结
Bacterial pneumonia can be complicated by the development of excess fluid and pus (pleural empyema) around the lungs in children. The incidence of pleural empyema in children has increased significantly in the last 10 years.
Short term morbidity for this condition is substantial, but unlike in adults, the long term outcome of this condition for children in developed countries is favourable. Inserting a chest drain and then adding a medicine (tissue plasminogen activator - tPA) to break down organized pus has been shown to be an effective therapy for reducing the duration of illness. However, this treatment is still suboptimal and prolonged hospitalization is common. Recent data from adults suggests that adding an additional medicine (DNase) to decrease the viscosity (thickness) of the fluid improves drainage and leads to better patient outcomes; however, there are no published studies on children.
This is a multi-centre randomized controlled trial comparing the time to discharge from hospital after chest drain insertion in previously well children who present with pleural empyema, treated with intrapleural DNase and tissue plasminogen activator (tPA) by chest drain for three doses over 48 hours compared with three doses over 48 hours of tPA alone. Other outcomes related to effectiveness, safety and cost will be assessed as well.
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
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 6 months to 18 years
- •hospitalized with diagnosis of pleural empyema requiring chest tube drainage with fibrinolytics as judged by the attending physician with the following criteria:
- •pneumonia with pleural effusion as documented on ultrasound of the chest; AND
- •need for further intervention in addition to antibiotics based on clinical criteria [persistent fever despite on antibiotics for at least 48 hours OR significant respiratory distress tachypnea, hypoxia) as a result of the pleural fluid collection]
排除标准
- •empyema as a result of tuberculosis, fungus or non-infectious causes (e.g. malignancy)
- •known coagulation impairment
- •suspected or proven allergy to tPA or DNase
- •chronic lung disease or other chronic illnesses (e.g. immunodeficiency or neurologic impairment)
- •child has already undergone a drainage procedure (e.g. chest drain or VATS).
- •recent administration of an investigational drug (within previous 30 days)
- •breastfeeding
研究组 & 干预措施
tPA and placebo
干预措施: TPA (Tissue Plasminogen Activator) (Drug)
tPA and placebo
干预措施: Placebo (Other)
tPA and DNase
干预措施: TPA (Tissue Plasminogen Activator) (Drug)
tPA and DNase
干预措施: DNase (Drug)
结局指标
主要结局
Time to Hospital Discharge
时间窗: up to 4 months
Time from insertion of the chest drain to discharge from hospital.
次要结局
- Time to Meeting Discharge Criteria(up to 4 months)
- Cost of the Hospitalization(up to 4 months)
- Time to Drain Removal(up to 4 months)
- Duration of Fever After Intervention(up to 4 months)
- Number of Participants With Serious Bleeding(up to 4 months)
- Number of Participants With Need for Ventilatory Support or Non-invasive Ventilation Following the Intervention(up to 4 months)
- Number of Participants With Further Interventions(up to 4 months)
- Number of Participants With Hospital Readmission(3 months post-discharge)
- Mortality(up to 4 months)
研究者
Eyal Cohen
Staff Physician
The Hospital for Sick Children