A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions
Purpose
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.
Condition
- Pleural Effusion
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- 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)
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 400,000 U LTI-01 |
400,000 U LTI-01 once a day (qd) x 3 days administered intrapleurally |
|
|
Experimental 800,000 U LTI-01 |
800,000 U LTI-01 qd x 3 days administered intrapleurally |
|
|
Experimental 1,200,000 U LTI-01 |
1,200,000 U LTI-01 qd x 3 days administered intrapleurally |
|
|
Placebo Comparator Placebo |
placebo (normal saline) 6ml qd x 3 days administered intrapleurally |
|
More Details
- Status
- Completed
- Sponsor
- Lung Therapeutics, Inc