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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00502632
Recruitment Status : Unknown
Verified May 2008 by Azienda Ospedaliera di Padova.
Recruitment status was:  Recruiting
First Posted : July 17, 2007
Last Update Posted : May 12, 2008
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Azienda Ospedaliera di Padova

Tracking Information
First Submitted Date  ICMJE July 16, 2007
First Posted Date  ICMJE July 17, 2007
Last Update Posted Date May 12, 2008
Study Start Date  ICMJE October 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2007)
  • Duration of hospital stay [ Time Frame: From beginning of intrapleural treatment ]
  • Need for additional surgical procedures [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2007)
  • Duration of suction applied to chest drain [ Time Frame: From beginning of intrapleural treatment ]
  • Duration of fever [ Time Frame: From beginning of intrapleural treatment ]
  • Duration of intravenous antibiotic treatment [ Time Frame: From beginning of intrapleural treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dornase Alfa and Urokinase for Kids With Pleural Empyema
Official Title  ICMJE Multicentre Randomized Double-Blinded Trial of Intrapleural Dornase Alfa and Urokinase vs Urokinase Alone for Complicated Parapneumonic Effusions in Children
Brief 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pleural Empyema
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1

    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
    Intervention: Drug: Urokinase and Dornase alfa
  • Placebo Comparator: 2

    Intrapleural administration of:

    • Urokinase 40,000 in 40ml normal saline, twice daily for 4 days
    • 25ml normal saline, twice daily for 4 days
    Intervention: Drug: Urokinase
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 16, 2007)		 94
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00502632
Other Study ID Numbers  ICMJE 1372P
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr PierGiorgio Gamba, Azienda Ospedaliera di Padova
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Azienda Ospedaliera di Padova
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Study Chair: PierGiorgio Gamba, MD Azienda Ospedaliera di Padova
Principal Investigator: Giorgio Stefanutti, MD Women's and Children's Hospital, Adelaide, SA
PRS Account Azienda Ospedaliera di Padova
Verification Date May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP