Dornase Alfa and Urokinase for Kids With Pleural Empyema

• Status: Unknown status
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether intrapleural treatment with Dornase alfa plus Urokinase improves clinical outcome compared to Urokinase alone in children with complicated parapneumonic effusions

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera di Padova
• Collaborator: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Age > 1 year and < 16 years

• Respiratory infection (pneumonia or lung abscess)

• Effusion occupying at least 1/3 of hemithorax on chest X-ray

• Complicated effusion (presence of at least one of the following):

• Hyperechoic pleural fluid on chest US scan

• Loculated collection on chest US or CT scan

• Purulent pleural fluid

• Positive culture or Gram stain on pleural fluid

Exclusion Criteria:

• Non parapneumonic effusion

• Immunodeficiency

• Neurological impairment

• Suspected or proven allergy to Urokinase or Dornase alfa

• Suspected or documented bronchopleural fistula

• Impaired coagulation (INR>2), haemorrhage, high risk for bleeding

• Thoracic surgical procedure (e.g. thoracoscopy, mini-thoracotomy) already performed

• Chest drain inserted since 6 or more days