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A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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)

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Study Stats
Protocol No.
20-001151
Category
Pulmonary Disease
Contact
Lloyd Liang
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04159831
For detailed technical eligibility, visit ClinicalTrials.gov.