Pleural Effusion
Conditions
Brief summary
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.
Interventions
DRUGLTI-01
single-chain urokinase plasminogen activator, scuPA
DRUGPlacebo
normal saline
Sponsors
Rein Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key 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. Key
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of referral to surgery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in pleural opacity | Post treatment (Day 4 or at time of treatment failure) | Change from baseline in absolute pleural opacity and relative change from baseline in pleural opacity volume assessed by chest CT at Day 4 |
Countries
United States
Outcome results
None listed