NCT04159831已完成2 期
A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-ranging Study Evaluating LTI-01 (Single-chain Urokinase Plasminogen Activator, scuPA) in Patients With Infected, Non-draining Pleural Effusions
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 33
- 主要终点
- Incidence of referral to surgery
研究概览
简要总结
The LTI-01-2001 study is a double-blind, placebo-controlled, Phase 2 study to evaluate LTI-01 (single-chain urokinase plasminogen activator, scuPA) in patients with infected, non-draining pleural effusions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female ≥ 18 years of age who provide written informed consent
- •Clinical presentation compatible with complicated parapneumonic pleural effusion (CPE), empyema or other type of pleural infection
- •Has pleural fluid requiring drainage as determined by chest ultrasonography or by chest CT, and which is either:
- •a) purulent; b) gram stain positive; c) culture positive; d) pH < 7.2; or e) glucose < 60 mg/dL (3.3 mmol/L)
- •Failure to adequately drain pleural fluid ≥ 3 hours post insertion of patent chest tube within the pleural space, as evidenced by one or more of the following criteria:
- •> 2 cm depth of fluid by ultrasound or CT
- •< 80% drainage from chest radiograph obtained prior to chest tube insertion.
排除标准
- •Current pleural infection already treated with intrapleural fibrinolytic therapy
- •Evidence of ipsilateral fibrothorax (e.g. CT scan with > 0.5 cm visceral pleural thickening)
- •History of multiple thoracenteses or thoracic surgical procedures within 3 months of screening
- •Previous pneumonectomy on the side of the pleural effusion
- •Current bilateral pleural infections
- •Known non-expandable lung prior to this pleural infection
- •Known or high clinical suspicion of a malignant pleural effusion
- •Existing indwelling or tunneled pleural catheter
- •Current infected hepatic hydrothorax or evidence of another abdominal process (e.g. pancreatic cyst or renal cyst) communicating with the pleural space
- •Active bleeding, or any condition in which bleeding is either a significant risk or would be difficult to manage
- •Fully anticoagulated patients on heparin, warfarin or novel oral anti-coagulants who are not able to temporarily discontinue anti-coagulants while receiving study medication and for 2 days after last dose of study medication Note: patients receiving low-molecular weight heparin for immobilization or anti-platelet agents are not excluded.
- •Presence of severe metabolic derangements that would interfere with study assessments
- •Systolic blood pressure >185 mmHg or diastolic blood pressure > 110 mmHg at screening
- •Hemodynamically unstable and/or requires use of intravenous vasopressor therapy
- •Expected survival < 3 months from a pathology other than the qualifying infected, non-draining pleural effusion (e.g. metastatic lung carcinoma)
研究组 & 干预措施
400,000 U LTI-01
Experimental
400,000 U LTI-01 once a day (qd) x 3 days administered intrapleurally
干预措施: LTI-01 (Drug)
800,000 U LTI-01
Experimental
800,000 U LTI-01 qd x 3 days administered intrapleurally
干预措施: LTI-01 (Drug)
1,200,000 U LTI-01
Experimental
1,200,000 U LTI-01 qd x 3 days administered intrapleurally
干预措施: LTI-01 (Drug)
Placebo
Placebo Comparator
placebo (normal saline) 6ml qd x 3 days administered intrapleurally
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of referral to surgery
时间窗: Post treatment (Day 4/Hospital discharge or at time of treatment failure)
Treatment failure, as evidenced by continued or worsening pleural sepsis and failure to adequately drain pleural effusion, resulting in referral to surgery
次要结局
- Relative change in pleural opacity(Post treatment (Day 4 or at time of treatment failure))
研究者
研究点 (33)
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