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

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: NCT00798278
Recruitment Status : Completed
First Posted : November 26, 2008
Last Update Posted : October 28, 2010
Sponsor:
Information provided by:
Spanish Society of Pediatric Surgery

Tracking Information
First Submitted Date  ICMJE November 25, 2008
First Posted Date  ICMJE November 26, 2008
Last Update Posted Date October 28, 2010
Study Start Date  ICMJE July 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2008)		 duration of the hospital stay after the treatment [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2008)
  • complications of the treatment and complications of the disease [ Time Frame: 3 months ]
  • total duration of the hospital stay [ Time Frame: 3 months ]
  • number of days carrying the chest drain [ Time Frame: 3 months ]
  • duration of the fever once the empyema has been drained [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood
Official Title  ICMJE Exploratory Multicentre Clinical Trial to Compare the Efficacy of Urokinase Versus Video-assisted Thoracoscopic for Treatment of Complicated Parapneumonic Empyema in Childhood
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Empyema
  • Pneumonia
Intervention  ICMJE
  • Drug: Urokinase
    Chest tube with intrapleural urokinase infusion for 3 days
  • Procedure: Video-Assisted Thoracoscopic
    Video-Assisted Thoracoscopic decortication
Study Arms  ICMJE
  • Experimental: Urokinase
    urokinase infusion for 3 days
    Intervention: Drug: Urokinase
  • Active Comparator: Thoracoscopic
    Video-Assisted Thoracoscopic
    Intervention: Procedure: Video-Assisted Thoracoscopic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 25, 2008)		 200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00798278
Other Study ID Numbers  ICMJE UKVATS2007
EudraCT Number 2007-003416-61
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Claudia Marhuenda Irastorza, University Hospital Vall d'Hebron. Barcelona
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Spanish Society of Pediatric Surgery
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Spanish Society of Pediatric Surgery
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP