Comparative Efficacy of Intrapleural Alteplase and Dornase Alfa Versus Video-Assisted Thoracoscopic Surgery in Patients with Pleural Empyema: A Randomized Controlled Trial

The primary objective of this randomized, controlled trial is to determine whether **surgery** up front is superior to drainage in patients with **pleural empyema**. This is clinically relevant as it aims to establish the most effective initial treatment strategy for managing pleural empyema, potentially improving patient outcomes and reducing complications associated with this condition. The study compares the efficacy of intrapleural fibrinolysis and DNase therapy versus video-assisted thoracoscopic surgery (VATS) in achieving optimal resolution of pleural empyema.

The clinical trial focuses on evaluating the effectiveness of surgical intervention versus drainage in patients diagnosed with **pleural empyema**. The study population includes both male and female participants, with an age range that corresponds to categories 3 and 4, indicating a broad age spectrum. The trial does not specifically target a vulnerable population. However, the sponsor has not provided information regarding the total number of participants involved in the study. Participants were selected based on criteria outlined in the study protocol, although specific lifestyle considerations such as diet, physical activity, or habits have not been detailed. The trial aims to provide insights into the optimal treatment approach for pleural empyema, contributing valuable data to the medical community.

The clinical trial is designed to evaluate the efficacy of **intrapleural fibrinolysis** and DNase compared to video-assisted thoracoscopic surgery (VATS) for the treatment of **pleural empyema**. This study is a randomized, controlled trial, which will be conducted in a double-blind manner to ensure unbiased results. The trial is expected to span from October 2021 to October 2026, with the primary objective being to determine if surgery is superior to drainage in patients with pleural empyema.

Participants will be involved in the study for a maximum treatment period of three months. The trial will include several key visits: an initial screening visit to assess eligibility based on the inclusion criteria, regular follow-up visits to monitor the participants' response to treatment, and an end-of-study visit to evaluate the overall outcomes. The inclusion visit will involve a comprehensive assessment to confirm the diagnosis of pleural empyema and ensure that participants meet the study's eligibility criteria. Follow-up visits will be scheduled at regular intervals to collect data on the efficacy and safety of the treatments being tested. The end-of-study visit will involve a final evaluation of the participants' health status and the collection of any remaining data required for the study's analysis.

Participants will receive either **dornase alfa** or **alteplase**, both administered via intrapleural use, with a maximum daily dose of 10 mg and 20 mg, respectively. The total dose for dornase alfa will not exceed 30 mg, while for alteplase, it will not exceed 60 mg over the treatment period. Conditions that may lead to early termination from the study include adverse reactions to the treatment, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial will adhere to strict ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants throughout the study duration.

The clinical trial involves the use of two experimental medications for the treatment of **pleural empyema**. The first medication is **Dornase Alfa**, which is administered as a nebuliser solution. The active substance, Dornase Alfa, is a protein of non-human origin. The medication is intended for **intrapleural use**. The maximum daily dose is 10 mg, with a total maximum dose of 30 mg over a treatment period of up to 3 days. The administration schedule and participant compliance are monitored to ensure adherence to the dosing regimen.

The second experimental medication is **Alteplase**, provided as a solution for injection or infusion. Like Dornase Alfa, Alteplase is a protein of non-human origin and is also administered via the intrapleural route. The maximum daily dose for Alteplase is 20 mg, with a total maximum dose of 60 mg over a treatment period of up to 3 days. Compliance with the dosing schedule is closely monitored to maintain the integrity of the trial results.

Both medications are used in the context of a randomized, controlled trial comparing intrapleural fibrinolysis and DNase therapy to video-assisted thoracoscopic surgery (VATS) for the treatment of pleural empyema. No non-experimental treatments, such as standard-of-care therapy or placebo, are specified in the trial protocol. The trial aims to determine whether surgical intervention is superior to drainage in managing this condition.

The clinical trial titled "Intrapleural Fibrinolysis and DNase versus VATS for the treatment of pleural empyema: a randomized, controlled trial" aims to evaluate the efficacy of two treatment approaches for **pleural empyema**. The trial will compare the outcomes of intrapleural fibrinolysis and DNase administration against video-assisted thoracoscopic surgery (VATS). The primary objective is to determine whether surgery is superior to drainage in patients with pleural empyema.