drugset / Trial / NCT03873766

Management of Pleural Space Infections

NCT03873766

Phase 4 Completed 26 enrolled Swedish Medical Center
RandomizedParallel-groupOpen-labelTreatment

Summary

Currently, there is no high-quality evidence comparing the clinical outcomes and cost effectiveness of surgical drainage combined with antibiotics versus dual-agent intrapleural fibrinolytic therapy (IPFT) catheter drainage of pleural space infections with concomitant antibiotic therapy. The absence of comparative data is a challenge for surgical and medical services in clinical decision-making for this common and morbid condition. This is a pilot study comparing surgical drainage of the pleural space in complex pleural effusions to bedside chest tube drainage using dual agent IPFT with the intent to inform on study algorithm and endpoint performance in anticipation of a multi-institutional randomized clinical trial.

Timeline

Start
2019-04-01
Primary completion
2022-03-11
Completion
2022-03-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Alteplase Protein / enzyme biologic 10 mg Other
Subject dornase alfa Protein / enzyme biologic 5 mg Other

Indications