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

Sponsor:	Spanish Society of Pediatric Surgery
Information provided by:	Spanish Society of Pediatric Surgery
ClinicalTrials.gov Identifier:	NCT00798278

Purpose

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).

Condition	Intervention	Phase
Empyema Pneumonia	Drug: Urokinase Procedure: Video-Assisted Thoracoscopic	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Exploratory Multicentre Clinical Trial to Compare the Efficacy of Urokinase Versus Video-assisted Thoracoscopic for Treatment of Complicated Parapneumonic Empyema in Childhood

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Urokinase

U.S. FDA Resources

Further study details as provided by Spanish Society of Pediatric Surgery:

Primary Outcome Measures:

duration of the hospital stay after the treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

complications of the treatment and complications of the disease [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
total duration of the hospital stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
number of days carrying the chest drain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
duration of the fever once the empyema has been drained [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	July 2008
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	1 Year to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00798278

Locations

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

Sponsors and Collaborators

Spanish Society of Pediatric Surgery

More Information

No publications provided

Responsible Party:	Claudia Marhuenda Irastorza, University Hospital Vall d'Hebron. Barcelona
ClinicalTrials.gov Identifier:	NCT00798278 History of Changes
Other Study ID Numbers:	UKVATS2007, EudraCT Number 2007-003416-61
Study First Received:	November 25, 2008
Last Updated:	October 27, 2010
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Spanish Society of Pediatric Surgery:

Empyema
Urokinase
Thoracoscopic
Childhood

Additional relevant MeSH terms:

Empyema
Pneumonia
Suppuration
Infection
Inflammation

Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on February 09, 2012