Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Rein Therapeutics
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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)
Clareo Health | A Study to Evaluate LTI-01 in Patients With Infected, Non-draining Pleural Effusions
