search
Back to results

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

Primary Purpose

Pleural Empyema

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Urokinase and Dornase alfa
Urokinase
Sponsored by
Azienda Ospedaliera di Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Empyema focused on measuring Pleural empyema, Pleural effusion, Dornase alfa, Urokinase, Children

Eligibility Criteria

1 Year - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedali Riuniti di BergamoRecruiting
  • Azienda Ospedaliera di PadovaRecruiting
  • Ospedale Bambino Gesu'Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

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

Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days 25ml normal saline, twice daily for 4 days

Outcomes

Primary Outcome Measures

Duration of hospital stay
Need for additional surgical procedures

Secondary Outcome Measures

Duration of suction applied to chest drain
Duration of fever
Duration of intravenous antibiotic treatment

Full Information

First Posted
July 16, 2007
Last Updated
May 9, 2008
Sponsor
Azienda Ospedaliera di Padova
Collaborators
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT00502632
Brief Title
Dornase Alfa and Urokinase for Kids With Pleural Empyema
Acronym
DUKE
Official Title
Multicentre Randomized Double-Blinded Trial of Intrapleural Dornase Alfa and Urokinase vs Urokinase Alone for Complicated Parapneumonic Effusions in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Azienda Ospedaliera di Padova
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Empyema
Keywords
Pleural empyema, Pleural effusion, Dornase alfa, Urokinase, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days 25ml normal saline, twice daily for 4 days
Intervention Type
Drug
Intervention Name(s)
Urokinase and Dornase alfa
Intervention Description
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 Type
Drug
Intervention Name(s)
Urokinase
Intervention Description
Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days 25ml normal saline, twice daily for 4 days
Primary Outcome Measure Information:
Title
Duration of hospital stay
Time Frame
From beginning of intrapleural treatment
Title
Need for additional surgical procedures
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Duration of suction applied to chest drain
Time Frame
From beginning of intrapleural treatment
Title
Duration of fever
Time Frame
From beginning of intrapleural treatment
Title
Duration of intravenous antibiotic treatment
Time Frame
From beginning of intrapleural treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
PierGiorgio Gamba, MD
Phone
+39 049 821 3683
Email
piergiorgio.gamba@unipd.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PierGiorgio Gamba, MD
Organizational Affiliation
Azienda Ospedaliera di Padova
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Giorgio Stefanutti, MD
Organizational Affiliation
Women's and Children's Hospital, Adelaide, SA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Cheli, MD
Email
mauriziocheli@tin.it
First Name & Middle Initial & Last Name & Degree
Maurizio Cheli, MD
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PierGiorgio Gamba, MD
Phone
+39 049 821 3683
Email
piergiorgio.gamba@unipd.it
First Name & Middle Initial & Last Name & Degree
Eleonora Cesca, MD
First Name & Middle Initial & Last Name & Degree
Sonia Viale, MD
Facility Name
Ospedale Bambino Gesu'
City
Roma
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Inserra, MD
Phone
+39 06 6859 2423
Email
lobina@opbg.net
First Name & Middle Initial & Last Name & Degree
Alessandro Inserra, MD

12. IPD Sharing Statement

Learn more about this trial

Dornase Alfa and Urokinase for Kids With Pleural Empyema

We'll reach out to this number within 24 hrs