Study comparing in children surgical drainage with medical drainage to evacuate the excess liquid around the lung in case of pneumonia

• Conditions: Parapneumonic pleural effusion; MedDRA version: 17.0Level: PTClassification code 10071699Term: Infectious pleural effusionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 17.0Level: PTClassification code 10014569Term: Empyema drainageSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-002221-35-BE
• Lead Sponsor: Hôpital Universitaire Des Enfants Reine Fabiola

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-01
• Last Update Posted: 9 March 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Eligible ages : 1 year to 15 years
- Eligible genders : both
- pleural fluid depth of at least 15mm, confirmed by ultrasound
- At least one of the following severity criteria :
1) fever continuing 48h after starting correct antibiotherapy
2) respiratory distress
3) mediastinal shift on the chest X-ray
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- previous drainage by either Video-Assisted Thoracoscopic or pleural drainage by percutaneous drain with or without fribrinolytic
- congenital pulmonary disorders with lung function impairment
- chronic pulmonary disease associated with lung function impairment
- hemodynamic instability
- acquired immune deficiency
- secondary immune deficiency induced
- coagulopathy disorder (contraindication of thrombolytic therapy)
- pregnancy or breastfeeding patient

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison of the efficacy, in terms of drainge duration, of pleural drainage by Video-Assisted Thoracoscopic with pleural drainage by percutaneous drain associated with urokinase in the treatment of parapneumonic pleural effusion in children<br>;Secondary Objective: Compare the two techniques in terms of efficacy, safety, tolerance and cost-effectiveness;Primary end point(s): Duration of drainage, in days;Timepoint(s) of evaluation of this end point: End of drainage is defined as a drainage of < 1ml/kg/24h