Dornase Alfa and Urokinase for Kids With Pleural Empyema

Phase 2

• Conditions: Pleural Empyema
• Interventions: Drug: Urokinase and Dornase alfa; Drug: Urokinase

• Registration Number: NCT00502632
• Lead Sponsor: Azienda Ospedaliera di Padova

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-17
• Study Start: 2007-10
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-09
• Last Update Posted: 2008-05-12
• Study Completion: 2009-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	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
2	Urokinase	Intrapleural administration of: * Urokinase 40,000 in 40ml normal saline, twice daily for 4 days * 25ml normal saline, twice daily for 4 days

Primary Outcome Measures

Name	Time	Method
Need for additional surgical procedures	3 months
Duration of hospital stay	From beginning of intrapleural treatment

Secondary Outcome Measures

Name	Time	Method
Duration of fever	From beginning of intrapleural treatment
Duration of intravenous antibiotic treatment	From beginning of intrapleural treatment
Duration of suction applied to chest drain	From beginning of intrapleural treatment

Trial Locations

Locations (3)

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

Ospedale Bambino Gesu'; 🇮🇹 Roma, Italy