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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Azienda Ospedaliera di Padova.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier:
NCT00502632
First received: July 16, 2007
Last updated: May 9, 2008
Last verified: May 2008
History of Changes
  Purpose

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 Intervention Phase
Pleural Empyema
 Drug: Urokinase and Dornase alfa
Drug: Urokinase
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera di Padova:

Primary Outcome Measures:
  • Duration of hospital stay [ Time Frame: From beginning of intrapleural treatment ] [ Designated as safety issue: No ]
  • Need for additional surgical procedures [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of suction applied to chest drain [ Time Frame: From beginning of intrapleural treatment ] [ Designated as safety issue: No ]
  • Duration of fever [ Time Frame: From beginning of intrapleural treatment ] [ Designated as safety issue: No ]
  • Duration of intravenous antibiotic treatment [ Time Frame: From beginning of intrapleural treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 94
Study Start Date: October 2007
Estimated Study Completion Date: October 2009
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502632

Contacts
Contact: PierGiorgio Gamba, MD +39 049 821 3683 piergiorgio.gamba@unipd.it

Locations
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
Study Chair: PierGiorgio Gamba, MD Azienda Ospedaliera di Padova
Principal Investigator: Giorgio Stefanutti, MD Women's and Children's Hospital, Adelaide, SA
  More Information

No publications provided

Responsible Party: Dr PierGiorgio Gamba, Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier: NCT00502632     History of Changes
Other Study ID Numbers: 1372P
Study First Received: July 16, 2007
Last Updated: May 9, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera di Padova:
Pleural empyema
Pleural effusion
Dornase alfa
Urokinase
Children

Additional relevant MeSH terms:
Empyema
Empyema, Pleural
Suppuration
Infection
Inflammation
 Pathologic Processes
Respiratory Tract Infections
Pleural Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013