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NCT00798278 Clinical Trial

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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00798278
Other study ID # UKVATS2007
Secondary ID EudraCT Number 2
Status Completed
Phase Phase 3
First received November 25, 2008
Last updated October 27, 2010
Start date July 2008
Est. completion date September 2010

Study information
Verified date November 2008
Source Spanish Society of Pediatric Surgery
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 15 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Urokinase
Chest tube with intrapleural urokinase infusion for 3 days
Procedure:
• Video-Assisted Thoracoscopic
Video-Assisted Thoracoscopic decortication

Locations
Country Name City State
Spain University Hospital Vall d'Hebron Barcelona
Spain Hospital Gregorio Marañón Madrid
Spain Hospital Infantil La Paz Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Hospital de Donostia San Sebastián Donostia

Sponsors (1)
Lead Sponsor Collaborator
Spanish Society of Pediatric Surgery

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary duration of the hospital stay after the treatment 3 months No
Secondary complications of the treatment and complications of the disease 3 months Yes
Secondary total duration of the hospital stay 3 months No
Secondary number of days carrying the chest drain 3 months No
Secondary duration of the fever once the empyema has been drained 3 months No
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