Clinical trial NCT04159831: A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions
Official title: A Phase 2, Randomized, Placebo-controlled, Double-blind, Dose-ranging Study Evaluating LTI-01 (Single-chain Urokinase Plasminogen Activator, scuPA) in Patients With Infected, Non-draining Pleural Effusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pleural Effusion
Lead sponsor: Rein Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-11-12
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Incidence of referral to surgery
timeFrame: Post treatment (Day 4/Hospital discharge or at time of treatment failure)
Secondary outcomes:
measure: Relative change in pleural opacity
timeFrame: Post treatment (Day 4 or at time of treatment failure)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: La Jolla
country: United States
facility: UC San Diego Health Jacobs Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California (UCLA)
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Group
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Health System
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: CHI CUMC Bergan Mercy
state: Nebraska
city: Queens
country: United States
facility: North Shore - Long Island Jewish Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Hershey
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Fairfax
country: United States
facility: INOVA
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: