Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood

October 27, 2010 updated by: Spanish Society of Pediatric Surgery

Exploratory Multicentre Clinical Trial to Compare the Efficacy of Urokinase Versus Video-assisted Thoracoscopic for Treatment of Complicated Parapneumonic Empyema in Childhood

A great controversy exists about which is the best method to perform the evacuation of the collection. The purpose of this study is to evaluate which is the best initial treatment to drain complicated parapneumonic empyema (stages II and III) in children: the present study raises a hypothesis of equivalence between both arms of treatment (chest drainage plus intrapleural urokinase or videothoracoscopic debridement).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • 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

  • Spain
      • Barcelona, Spain, 08035
        • University Hospital Vall d'Hebron
      • Madrid, Spain
        • Hospital Gregorio Maranon
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Infantil La Paz
    • Asturias
      • Oviedo, Asturias, Spain
        • Hospital Universitario Central de Asturias
    • Donostia
      • San Sebastián, Donostia, Spain, 20014
        • Hospital de Donostia

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

1 year to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients less than 15 years of age with pneumonia and persistent fever, and complicated parapneumonic empyema (septation or loculation seen on ultrasound or Rx thorax)stages II and III requiring an intervention to drain

Exclusion Criteria:

  • Existing contraindications or other previous conditions, hypertension, pneumothorax

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Urokinase
urokinase infusion for 3 days
Drug: Urokinase
Chest tube with intrapleural urokinase infusion for 3 days
Active Comparator: Thoracoscopic
Video-Assisted Thoracoscopic
Procedure: Video-Assisted Thoracoscopic
Video-Assisted Thoracoscopic decortication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
duration of the hospital stay after the treatment
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
complications of the treatment and complications of the disease
Time Frame: 3 months
3 months
total duration of the hospital stay
Time Frame: 3 months
3 months
number of days carrying the chest drain
Time Frame: 3 months
3 months
duration of the fever once the empyema has been drained
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Spanish Society of Pediatric Surgery

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

July 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 25, 2008

First Posted (Estimate)

November 26, 2008

Study Record Updates

Last Update Posted (Estimate)

October 28, 2010

Last Update Submitted That Met QC Criteria

October 27, 2010

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKVATS2007
  • EudraCT Number 2007-003416-61

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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