Dornase Alfa and Urokinase for Kids With Pleural Empyema
Information source: Azienda Ospedaliera di Padova
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pleural Empyema
Intervention: Urokinase and Dornase alfa (Drug); Urokinase (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Azienda Ospedaliera di Padova Official(s) and/or principal investigator(s): PierGiorgio Gamba, MD, Study Chair, Affiliation: Azienda Ospedaliera di Padova Giorgio Stefanutti, MD, Principal Investigator, Affiliation: Women's and Children's Hospital, Adelaide, SA
Overall contact: PierGiorgio Gamba, MD, Phone: +39 049 821 3683, Email: piergiorgio.gamba@unipd.it
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
Clinical Details
Official title: Multicentre Randomized Double-Blinded Trial of Intrapleural Dornase Alfa and Urokinase vs Urokinase Alone for Complicated Parapneumonic Effusions in Children
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Duration of hospital stayNeed for additional surgical procedures
Secondary outcome: Duration of suction applied to chest drainDuration of fever Duration of intravenous antibiotic treatment
Eligibility
Minimum age: 1 Year.
Maximum age: 16 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
PierGiorgio Gamba, MD, Phone: +39 049 821 3683, Email: piergiorgio.gamba@unipd.it
Ospedali Riuniti di Bergamo, Bergamo 24128, Italy; Recruiting Maurizio Cheli, MD, Email: mauriziocheli@tin.it Maurizio Cheli, MD, Principal Investigator
Azienda Ospedaliera di Padova, Padova 35128, Italy; Recruiting PierGiorgio Gamba, MD, Phone: +39 049 821 3683, Email: piergiorgio.gamba@unipd.it Eleonora Cesca, MD, Sub-Investigator Sonia Viale, MD, Sub-Investigator
Ospedale Bambino Gesu', Roma 00165, Italy; Recruiting Alessandro Inserra, MD, Phone: +39 06 6859 2423, Email: lobina@opbg.net Alessandro Inserra, MD, Principal Investigator
Additional Information
Starting date: October 2007
Last updated: May 9, 2008
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