Dornase Alfa and Urokinase for Kids With Pleural Empyema
NCT00502632 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 94
Last updated 2008-05-12
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
Conditions
- Pleural Empyema
Interventions
- 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
- DRUG
-
Urokinase
Intrapleural administration of: * Urokinase 40,000 in 40ml normal saline, twice daily for 4 days * 25ml normal saline, twice daily for 4 days
Sponsors & Collaborators
- collaborator INDUSTRY
-
Azienda Ospedaliera di Padova
lead OTHER
Principal Investigators
-
PierGiorgio Gamba, MD · Azienda Ospedaliera di Padova
-
Giorgio Stefanutti, MD · Women's and Children's Hospital, Adelaide, SA
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-10-31
- Completion
- 2009-10-31
Countries
- Italy
Study Locations
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