A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions
- Registration Number
- NCT04159831
- Lead Sponsor
- Lung Therapeutics, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description 400,000 U LTI-01 LTI-01 400,000 U LTI-01 once a day (qd) x 3 days administered intrapleurally 800,000 U LTI-01 LTI-01 800,000 U LTI-01 qd x 3 days administered intrapleurally 1,200,000 U LTI-01 LTI-01 1,200,000 U LTI-01 qd x 3 days administered intrapleurally Placebo Placebo placebo (normal saline) 6ml qd x 3 days administered intrapleurally
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (33)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
University of California (UCLA)
🇺🇸Los Angeles, California, United States
UC San Diego Health Jacobs Medical Center
🇺🇸La Jolla, California, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
North Shore - Long Island Jewish Medical Center
🇺🇸Queens, New York, United States
The Pennsylvania State University
🇺🇸Hershey, Pennsylvania, United States
The University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
INOVA
🇺🇸Fairfax, Virginia, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
CHI CUMC Bergan Mercy
🇺🇸Omaha, Nebraska, United States
Duke University
🇺🇸Durham, North Carolina, United States
Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
The University of Texas Health Science Center
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
The University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Temple University
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
UC Davis Medical Group
🇺🇸Sacramento, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
St. Luke's Health System
🇺🇸Kansas City, Missouri, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States