NCT04915586

Short Duration High Intensity Intrapleural Alteplase With Pulmozyme in Pleural Infection Management

Short Duration High Intensity Intrapleural Alteplase With Pulmozyme (DNase) in Pleural Infection Management- Single Centre Experience

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National University of Malaysia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to assess the efficacy of the modified regimen short duration intrapleural 16mg alteplase (Actilyse, Boehringer Ingelheim) with 5mg DNase (Pulmozyme Hoffmann-La Roche Ltd) in patients with pleural infection.

Detailed description

The regimen 10 mg alteplase and 5 mg DNase twice daily that was used in MIST-2 trial is still an empiric choice. The rationale of using 3 doses of 16 mg alteplase dose (with supplementary 5 mg DNase) in our study was governed by the formulation of alteplase in our country (50 mg per ampoule); hence, it is best used within 24 hours following reconstitution as its biochemical stability up to 24 hours as assessed by in vitro clot lysis assays.

Conditions

• Loculated Empyema

Interventions

Type	Name	Description
DRUG	Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg	Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours

Timeline

• Start date: 2019-12-30
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2021-06-07
• Last updated: 2021-06-07

Locations

1 site across 1 country: Malaysia