drugset / Trial / NCT03873766
Management of Pleural Space Infections
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alteplase | Protein / enzyme biologic | 10 mg | Other |
| Subject | dornase alfa | Protein / enzyme biologic | 5 mg | Other |