Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood
Exploratory Multicentre Clinical Trial to Compare the Efficacy of Urokinase Versus Video-assisted Thoracoscopic for Treatment of Complicated Parapneumonic Empyema in Childhood
2 other identifiers
interventional
200
1 country
6
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2008
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 25, 2008
CompletedFirst Posted
Study publicly available on registry
November 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedOctober 28, 2010
November 1, 2008
2.2 years
November 25, 2008
October 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
duration of the hospital stay after the treatment
3 months
Secondary Outcomes (4)
complications of the treatment and complications of the disease
3 months
total duration of the hospital stay
3 months
number of days carrying the chest drain
3 months
duration of the fever once the empyema has been drained
3 months
Study Arms (2)
Urokinase
EXPERIMENTALurokinase infusion for 3 days
Thoracoscopic
ACTIVE COMPARATORVideo-Assisted Thoracoscopic
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Existing contraindications or other previous conditions, hypertension, pneumothorax
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University Hospital Vall d'Hebron
Barcelona, Barcelona, 08035, Spain
Hospital de Donostia
San Sebastián, Donostia, 20014, Spain
Hospital Gregorio Marañón
Madrid, Madrid, Spain
Hospital Infantil La Paz
Madrid, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 25, 2008
First Posted
November 26, 2008
Study Start
July 1, 2008
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
October 28, 2010
Record last verified: 2008-11