Dornase Alfa and Urokinase for Kids With Pleural Empyema

Pleural Empyema Clinical Trial

— DUKE  

Official title:

Multicentre Randomized Double-Blinded Trial of Intrapleural Dornase Alfa and Urokinase vs Urokinase Alone for Complicated Parapneumonic Effusions in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00502632
• Other study ID #: 1372P
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 16, 2007
• Last updated: May 9, 2008
• Start date: October 2007
• Est. completion date: October 2009

Study information

• Verified date: May 2008
• Source: Azienda Ospedaliera di Padova
• Contact: PierGiorgio Gamba, MD
• Phone: +39 049 821 3683
• Email: piergiorgio.gamba[@]unipd.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Empyema
• Empyema, Pleural
• Pleural Empyema

Intervention

Drug:
• Urokinase and Dornase alfa
Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days
• Urokinase
Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days 25ml normal saline, twice daily for 4 days

Locations

Country	Name	City	State
Italy	Ospedali Riuniti di Bergamo	Bergamo
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Ospedale Bambino Gesu'	Roma

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova	Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of hospital stay		From beginning of intrapleural treatment	No
Primary	Need for additional surgical procedures		3 months	No
Secondary	Duration of suction applied to chest drain		From beginning of intrapleural treatment	No
Secondary	Duration of fever		From beginning of intrapleural treatment	No
Secondary	Duration of intravenous antibiotic treatment		From beginning of intrapleural treatment	No