Dornase Alfa and Urokinase for Kids With Pleural Empyema (DUKE)

University of Padua

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pleural Empyema

Treatments: Drug: Urokinase; Drug: Urokinase and Dornase alfa

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00502632

1372P

Details and patient eligibility

About

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

Enrollment: 94 estimated patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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

Treatment:

Drug: Urokinase and Dornase alfa

2

Placebo Comparator group

Description:

Intrapleural administration of: * Urokinase 40,000 in 40ml normal saline, twice daily for 4 days * 25ml normal saline, twice daily for 4 days

Treatment:

Drug: Urokinase