A Study to Evaluate LTI-01 in Patients With Infected, Non... | NCT04159831

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
400,000 U LTI-01	Experimental	400,000 U LTI-01 once a day (qd) x 3 days administered intrapleurally	Drug: LTI-01
800,000 U LTI-01	Experimental	800,000 U LTI-01 qd x 3 days administered intrapleurally	Drug: LTI-01
1,200,000 U LTI-01	Experimental	1,200,000 U LTI-01 qd x 3 days administered intrapleurally	Drug: LTI-01
Placebo	Placebo Comparator	placebo (normal saline) 6ml qd x 3 days administered intrapleurally	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
LTI-01	Drug	single-chain urokinase plasminogen activator, scuPA	1,200,000 U LTI-01 400,000 U LTI-01 800,000 U LTI-01

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of referral to surgery	Treatment failure, as evidenced by continued or worsening pleural sepsis and failure to adequately drain pleural effusion, resulting in referral to surgery	Post treatment (Day 4/Hospital discharge or at time of treatment failure)

Secondary Outcomes

Measure	Description	Time Frame
Relative change in pleural opacity	Change from baseline in absolute pleural opacity and relative change from baseline in pleural opacity volume assessed by chest CT at Day 4	Post treatment (Day 4 or at time of treatment failure)

Eligibility Module

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)

Facility	Status	City	State	ZIP	Country	Contacts
The University of Alabama at Birmingham		Birmingham	Alabama	35294	United States
UC San Diego Health Jacobs Medical Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42310706	Derived	Lamb CR, Akulian J, Musani A, Shojaee S, Chen A, Kurman J, Jani P, Senitko M, Ahmad D, Wahidi M, Ansari S, Abu-Hijleh M, Ma KC, Puchalski J, Yarmus L, Kheir F, Maldonado F, Cheng G, Alvarado C, Karan SP, Windsor B, Rahman NM, Shoemaker S, Idell S. The LTI-01-2001 phase 2a trial of intrapleural LTI-01 in patients with infected, non-draining pleural effusions. Respir Res. 2026 Jun 17. doi: 10.1186/s12931-026-03782-4. Online ahead of print.

ID	Term
D010995	Pleural Diseases
D012140	Respiratory Tract Diseases