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

Prospective Randomized Study Comparing the Efficacy and Safety of Pleural Drainage by Video-Assisted Thoracoscopic With Pleural Drain Associated With Urokinase in the Treatment of Parapneumonic Pleural Effusion in Children - UROVATS

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002221-35-BE

Enrollment

Registered

2014-08-01

Start date

2014-12-18

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parapneumonic pleural effusion MedDRA version: 17.0 Level: PT Classification code 10071699 Term: Infectious pleural effusion System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.0 Level: PT Classification code 10014569 Term: Empyema drainage System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Actosolv 100 000 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: UROKINASE CAS Number: 9039-53-6 Concentration unit: IU international unit(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 ;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	—

Measure

Time frame

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 ;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

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Secondary

Measure	Time frame
Secondary end point(s): - Mortality rate - Length of hospital stay - Duration of oxygen therapy - Duration of intravenous antibiotic therapy - Duration of fever > 38.5°C after the initiation of therapy - Patient disconfort - serious and non-serious adverse event related to the therapy - Inflammatory markers measurement - Cost-effectiveness;Timepoint(s) of evaluation of this end point: - Evaluation of coagulation parameters at 48H post therapy initiation and at the drain removal (safety) - Serious and non serious adverse events recorded throughout the patient hospital stay (safety) - Safety visit performed 3 months after patient hospital discharged. - Duration in terms of days for (length of hospital stay, duration of oxygen therapy, duration of intravenous antibiotic therapy, duration of fever > 38.5°C after therapy initiation (efficacy) - Evaluation of leucocyte, neutrophile count, and CRP at 48H post therapy initiation and at the drain removal (efficacy) - Post-therapy initiation analgesic consumption until patient hospital discharge (tolerability)	—

Measure

Time frame

Secondary end point(s): - Mortality rate - Length of hospital stay - Duration of oxygen therapy - Duration of intravenous antibiotic therapy - Duration of fever > 38.5°C after the initiation of therapy - Patient disconfort - serious and non-serious adverse event related to the therapy - Inflammatory markers measurement - Cost-effectiveness;Timepoint(s) of evaluation of this end point: - Evaluation of coagulation parameters at 48H post therapy initiation and at the drain removal (safety) - Serious and non serious adverse events recorded throughout the patient hospital stay (safety) - Safety visit performed 3 months after patient hospital discharged. - Duration in terms of days for (length of hospital stay, duration of oxygen therapy, duration of intravenous antibiotic therapy, duration of fever > 38.5°C after therapy initiation (efficacy) - Evaluation of leucocyte, neutrophile count, and CRP at 48H post therapy initiation and at the drain removal (efficacy) - Post-therapy initiation analgesic consumption until patient hospital discharge (tolerability)

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Countries

Belgium

Contacts

Public ContactClinical Research Unit

Hôpital Universitaire Des Enfants Reine Fabiola

bernard.wenderickx@huderf.be003224773654

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026