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| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Intrapleural administration of:
|
|
| 2 | Placebo Comparator | Intrapleural administration of:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urokinase and Dornase alfa | Drug | Intrapleural administration of:
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospital stay | From beginning of intrapleural treatment | |
| Need for additional surgical procedures | 3 months |
| 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 |
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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):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PierGiorgio Gamba, MD | Contact | +39 049 821 3683 | piergiorgio.gamba@unipd.it |
| Name | Affiliation | Role |
|---|---|---|
| PierGiorgio Gamba, MD | Azienda Ospedaliera di Padova | Study Chair |
| Giorgio Stefanutti, MD | Women's and Children's Hospital, Adelaide, SA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedali Riuniti di Bergamo | Recruiting | Bergamo | 24128 | Italy |
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| ID | Term |
|---|---|
| D016724 | Empyema, Pleural |
| D010996 | Pleural Effusion |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D004653 | Empyema |
| D013492 | Suppuration |
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| ID | Term |
|---|---|
| D014568 | Urokinase-Type Plasminogen Activator |
| C568813 | dornase alfa |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Urokinase | Drug | Intrapleural administration of:
|
|
| From beginning of intrapleural treatment |
| Azienda Ospedaliera di Padova | Recruiting | Padova | 35128 | Italy |
|
| Ospedale Bambino Gesu' | Recruiting | Roma | 00165 | Italy |
|
| D010995 |
| Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |