A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions
NCT ID: NCT04159831
Last Updated: 2023-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2020-09-26
2022-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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400,000 U LTI-01
400,000 U LTI-01 once a day (qd) x 3 days administered intrapleurally
LTI-01
single-chain urokinase plasminogen activator, scuPA
800,000 U LTI-01
800,000 U LTI-01 qd x 3 days administered intrapleurally
LTI-01
single-chain urokinase plasminogen activator, scuPA
1,200,000 U LTI-01
1,200,000 U LTI-01 qd x 3 days administered intrapleurally
LTI-01
single-chain urokinase plasminogen activator, scuPA
Placebo
placebo (normal saline) 6ml qd x 3 days administered intrapleurally
Placebo
normal saline
Interventions
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LTI-01
single-chain urokinase plasminogen activator, scuPA
Placebo
normal saline
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Rein Therapeutics
INDUSTRY
Responsible Party
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Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
UC San Diego Health Jacobs Medical Center
La Jolla, California, United States
University of California (UCLA)
Los Angeles, California, 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
Rush University Medical Center
Chicago, Illinois, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
St. Luke's Health System
Kansas City, Missouri, United States
Washington University
St Louis, Missouri, United States
CHI CUMC Bergan Mercy
Omaha, Nebraska, United States
North Shore - Long Island Jewish Medical Center
Queens, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
The Pennsylvania State University
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
The University of Texas Health Science Center
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
INOVA
Fairfax, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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LTI-01-2001
Identifier Type: -
Identifier Source: org_study_id
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