Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Pleural Empyema Drug: Urokinase and Dornase alfa Drug: Urokinase Phase 2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentre Randomized Double-Blinded Trial of Intrapleural Dornase Alfa and Urokinase vs Urokinase Alone for Complicated Parapneumonic Effusions in Children
Study Start Date : October 2007
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
 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
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
 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Duration of hospital stay [ Time Frame: From beginning of intrapleural treatment ]
  2. Need for additional surgical procedures [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Duration of suction applied to chest drain [ Time Frame: From beginning of intrapleural treatment ]
  2. Duration of fever [ Time Frame: From beginning of intrapleural treatment ]
  3. Duration of intravenous antibiotic treatment [ Time Frame: From beginning of intrapleural treatment ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502632


Contacts
Layout table for location contacts
Contact: PierGiorgio Gamba, MD +39 049 821 3683 piergiorgio.gamba@unipd.it

Locations
Layout table for location information
Italy
Ospedali Riuniti di Bergamo Recruiting
Bergamo, Italy, 24128
Contact: Maurizio Cheli, MD       mauriziocheli@tin.it   
Principal Investigator: Maurizio Cheli, MD         
Azienda Ospedaliera di Padova Recruiting
Padova, Italy, 35128
Contact: PierGiorgio Gamba, MD    +39 049 821 3683    piergiorgio.gamba@unipd.it   
Sub-Investigator: Eleonora Cesca, MD         
Sub-Investigator: Sonia Viale, MD         
Ospedale Bambino Gesu' Recruiting
Roma, Italy, 00165
Contact: Alessandro Inserra, MD    +39 06 6859 2423    lobina@opbg.net   
Principal Investigator: Alessandro Inserra, MD         
Sponsors and Collaborators
Azienda Ospedaliera di Padova
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Chair: PierGiorgio Gamba, MD Azienda Ospedaliera di Padova
Principal Investigator: Giorgio Stefanutti, MD Women's and Children's Hospital, Adelaide, SA
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dr PierGiorgio Gamba, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT00502632    
Other Study ID Numbers: 1372P
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: May 12, 2008
Last Verified: May 2008
Keywords provided by Azienda Ospedaliera di Padova:
Pleural empyema
Pleural effusion
Dornase alfa
Urokinase
Children
Additional relevant MeSH terms:
Layout table for MeSH terms
Empyema
Empyema, Pleural
Suppuration
Infections
Inflammation
 Pathologic Processes
Respiratory Tract Infections
Pleural Diseases
Respiratory Tract Diseases