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

Condition(s) targeted: Empyema; Pneumonia

Intervention: Urokinase (Drug); Video-Assisted Thoracoscopic (Procedure)

Phase: Phase 3

Status: Recruiting

Sponsored by: Spanish Society of Pediatric Surgery

Overall contact:
Marhuenda Claudia, MD, Email: cmarhuen@vhebron.net

A great controversy exists about which is the best method to perform the evacuation of the collection. 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).

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: duration of the hospital stay after the treatment

Secondary outcome:

complications of the treatment and complications of the disease

total duration of the hospital stay

number of days carrying the chest drain

duration of the fever once the empyema has been drained

Minimum age: 1 Year. Maximum age: 15 Years. Gender(s): Both.

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

Marhuenda Claudia, MD, Email: cmarhuen@vhebron.net

University Hospital Vall d'Hebron, Barcelona 08035, Spain; Recruiting
Marhuenda Claudia, MD, Email: cmarhuen@vhebron.net
Marhuenda Claudia, MD, Principal Investigator

Hospital Universitario 12 de Octubre, Madrid, Spain; Recruiting
Cano Indalecio
Cano Indalecio, MD, Principal Investigator

Hospital Infantil La Paz, Madrid, Spain; Recruiting
Hernandez Francisco, MD
Hernandez Francisco, MD, Principal Investigator

Hospital Gregorio Marañón, Madrid, Spain; Recruiting
Matute A Jose, MD
Matute A Jose, MD, Principal Investigator

Hospital La Fe, Valencia, Spain; Recruiting
Gutierrez Carlos, MD
Gutierrez Carlos, MD, Principal Investigator

Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain; Recruiting
Alvarez Victor
Alvarez Vistor, MD, Principal Investigator

Starting date: July 2008
Last updated: November 25, 2008