Once Daily Intrapleural Enzyme Therapy in Complicated Parapneumonic Effusion or Empyema (ONLY ONCE)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 12
- 主要终点
- IET Failure: Surgery and/or mortality at 90 days
研究概览
简要总结
The goal of this clinical trial is to find out if giving certain medications once a day works just as well as giving them twice a day to treat infections around the lungs (called pleural infections). These medications-tissue plasminogen activator (tPA) and deoxyribonuclease (DNase)-are placed through a chest tube into the space between the lung and the chest wall to help clear out the infection.
The investigators are trying to learn:
- Does using the medicine once a day work just as well as using it twice a day?
- Are there any differences in outcomes between patients who get the medicine once a day versus twice a day?
- Does more or less fluid remain in the chest (seen on a chest x-ray) depending on how often the medicine is given?
Participants will:
- Have an infection around their lung and will already be getting normal hospital care, including a chest tube to drain the infected fluid around their lung.
- Be asked to give permission to join the study.
- Be randomly chosen (like flipping a coin) to get the medications either once a day or twice a day through the chest tube.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Written informed consent obtained from patient or patient's legally authorized representative (LAR) to participate in the study and HIPAA authorization for release of personal health information.
- Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- Age ≥ 18 years at the time of consent.
- Patient is admitted to the hospital and with a pleural effusion that is drained with a small-bore chest tube or one that allows for administration of IET
- Pleural fluid that is one of the following:
- Macroscopically purulent or pleural fluid gram stain or culture positive for bacteria (ii) potential of hydrogen (pH) < 7.2 (iii) Pleural fluid glucose < 60mg/dL (iv) Pleural fluid Lactate Dehydrogenase (LDH) > 1,000 IU/L
- Patient is deemed a candidate to receive intrapleural enzyme therapy as defined by having a residual collection or persistent sepsis 24 hours after initial chest tube placement
排除标准
- Known pregnancy or lactating females
- Prisoners
- Age <18 years at time of consent
- Previous treatment with intra-pleural fibrinolytic agents, DNase, or both during the same hospital admission
- Known sensitivity or allergic reaction to DNAse or tPA
- Coincidental stroke, major hemorrhage (requiring blood transfusions within the last 5 days), major trauma, or major surgery within the last 5 days
- Previous pneumonectomy or active bronchopleural fistula on the affected side
- Therapeutic systemic anticoagulation or antiplatelet agents that cannot held for more than 48 hours prior to IET administration
- Expected survival of less than 3 months due to a pathologic condition other than that causing the pleural infection
研究组 & 干预措施
Once daily intrapleural enzyme therapy
Participants will receive intrapleural enzyme therapy (IET) once daily for 3 consecutive days.
干预措施: Fibrinolytic once daily (Drug)
Once daily intrapleural enzyme therapy
Participants will receive intrapleural enzyme therapy (IET) once daily for 3 consecutive days.
干预措施: DNA degradation once daily (Drug)
Twice daily intrapleural enzyme therapy
Participants will receive intrapleural enzyme therapy (IET) twice daily for 3 consecutive days.
干预措施: Fibrinolytic twice daily (Drug)
Twice daily intrapleural enzyme therapy
Participants will receive intrapleural enzyme therapy (IET) twice daily for 3 consecutive days.
干预措施: DNA degradation twice daily (Drug)
结局指标
主要结局
IET Failure: Surgery and/or mortality at 90 days
时间窗: 90 days
Measure the rate of IET failure (defined as surgery and/or mortality at 90 days) in both once daily IET and twice daily IET groups.
IET Failure: Surgery and/or mortality at 90 days
时间窗: 90 days
Measure the rate of IET failure (defined as surgery and/or mortality at 90 days) in both once daily IET and twice daily IET groups.
次要结局
- Change in C-reactive Protein (CRP) level(From enrollment until day 3 of intervention)
- Chest tube drainage amount(From enrollment until day 3 of intervention)
- Duration of chest tube placement(90 days)
- 30 Day Mortality(30 days)
- Hospital length of stay(90 days)
- Oral Morphine Equivalents (OME)(From enrollment until day 3 of intervention)
- Change of White Blood Cell Count(From enrollment until day 3 of intervention)
- 30 Day Mortality(30 days)
- Hospital length of stay(90 days)
- Oral Morphine Equivalents (OME)(From enrollment until day 3 of intervention)
- Change of White Blood Cell Count(From enrollment until day 3 of intervention)
- Change in C-reactive Protein (CRP) level(From enrollment until day 3 of intervention)
- Change in Fever(From enrollment until day 3 of intervention)
- Chest tube drainage amount(From enrollment until day 3 of intervention)
- Duration of chest tube placement(90 days)
- Difference in pleural opacification on chest x-ray imaging between once daily IET and twice daily IET(From enrollment to 48 hours after completing 3 days of intrapleural enzyme therapy)
- Percent of participants who have pleural hemorrhage requiring blood transfusion(From enrollment to 48 hours after completing 3 days of intrapleural enzyme therapy)
研究者
研究点 (12)
标识符
- NCT 编号
- NCT07095361
- 其他研究编号
- 24-1309
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (6个月前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.