Dornase Alfa and Urokinase for Kids With Pleural Empyema

Study Overview
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Brief Summary
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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

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

Conditions
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Pleural Empyema

Intervention / Treatment
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* Drug: Urokinase and Dornase alfa
* Drug: Urokinase


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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 | Drug: Urokinase and Dornase alfa<br>* 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<br>|
| Placebo Comparator: 2<br>Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days 25ml normal saline, twice daily for 4 days | Drug: Urokinase<br>* Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days 25ml normal saline, twice daily for 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay |  | From beginning of intrapleural treatment | 
| Need for additional surgical procedures |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of suction applied to chest drain |  | From beginning of intrapleural treatment | 
| Duration of fever |  | From beginning of intrapleural treatment | 
| Duration of intravenous antibiotic treatment |  | From beginning of intrapleural treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pleural empyema, Pleural effusion, Dornase alfa, Urokinase, Children