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

May 9, 2008 updated by: Azienda Ospedaliera di Padova

Multicentre Randomized Double-Blinded Trial of Intrapleural Dornase Alfa and Urokinase vs Urokinase Alone for Complicated Parapneumonic Effusions in Children

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

94

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bergamo, Italy, 24128
        • Recruiting
        • Ospedali Riuniti di Bergamo
        • Contact:
        • Principal Investigator:
          • Maurizio Cheli, MD
      • Padova, Italy, 35128
        • Recruiting
        • Azienda Ospedaliera Di Padova
        • Contact:
        • Sub-Investigator:
          • Eleonora Cesca, MD
        • Sub-Investigator:
          • Sonia Viale, MD
      • Roma, Italy, 00165
        • Recruiting
        • Ospedale Bambino Gesu'
        • Contact:
          • Alessandro Inserra, MD
          • Phone Number: +39 06 6859 2423
          • Email: lobina@opbg.net
        • Principal Investigator:
          • Alessandro Inserra, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of hospital stay
Time Frame: From beginning of intrapleural treatment
From beginning of intrapleural treatment
Need for additional surgical procedures
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of suction applied to chest drain
Time Frame: From beginning of intrapleural treatment
From beginning of intrapleural treatment
Duration of fever
Time Frame: From beginning of intrapleural treatment
From beginning of intrapleural treatment
Duration of intravenous antibiotic treatment
Time Frame: From beginning of intrapleural treatment
From beginning of intrapleural treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera di Padova

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Completion (Anticipated)

October 1, 2009

Study Registration Dates

First Submitted

July 16, 2007

First Submitted That Met QC Criteria

July 16, 2007

First Posted (Estimate)

July 17, 2007

Study Record Updates

Last Update Posted (Estimate)

May 12, 2008

Last Update Submitted That Met QC Criteria

May 9, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1372P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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