Pilot Study Comparing Low and Standard Dose Intrapleural Tissue Plasminogen Activator for Treating Pleural Infection Evaluating Effectiveness and Bleeding Risk with Follow-Up to 3 Months

What this Trial Is About

Researchers are evaluating the feasibility of a randomized clinical trial comparing low 2.5mg and standard 10mg doses of intrapleural tissue plasminogen activator tPA combined with deoxyribonuclease DNase in patients with unresolved pleural infection. Pleural infection, often linked to pneumonia, leads to serious complications and can be difficult to treat with antibiotics and drainage alone. The study aims to determine if a lower dose of tPA is feasible and acceptable, potentially reducing bleeding risks associated with higher doses. Participants will be randomly assigned to receive up to six doses of intrapleural tPA with DNase, starting at either 2.5mg or 10mg. The treatment is given directly into the pleural space. After the third dose, doctors may decide to continue the assigned dose or switch to an open-label 10mg dose based on the patients response. The study is designed to closely mimic real-world clinical use and allows flexibility in dosing. During the study, participants will be followed up until 3 months after hospital discharge. Researchers will monitor clinical outcomes, including survival, need for surgery, additional interventions, and bleeding complications. They will also assess radiographic responses, pleural fluid output, hospital stay length, and patient-reported outcomes. The main focus is on whether the trial protocol is practical, including enrollment and retention rates, along with safety monitoring and compliance with the treatment regimen.

Trial of Reduced Alteplase Dose for Parapneumonic Effusion (TRAPPE)