Empyema, PleuralPhase 3UROVATSNCT02165891
Comparison of Intrapleural Urokinase and Video-Assisted Thorascopic Surgery in the Treatment of Parapneumonic Pleural Effusion in Children
A Phase 3 study testing insertion of a chest drain with urokinase instillation and primary video-assisted thorascopic surgery in people with Empyema, Pleural, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
Trial summary
Despite the improvement in the technology available for diagnosing and treating empyema, the management of empyema in children remains controversial. The purpose of this study is to compare the efficacy and safety of two common technical approach used for pleural effusion drainage in the treatment of childhood empyema. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Empyema, Pleural
- What is being tested?
- insertion of a chest drain with urokinase instillation and primary video-assisted thorascopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2015to Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients under the age of 17
- pleural fluid depth of at least 15mm, confirmed by ultrasound
- at least one of the following severity criteria :
- fever continuing 48h after starting correct antibiotherapy
- respiratory distress
- mediastinal displacement on the chest X-ray
Who cannot join
- previous drainage by either Video-Assisted Thoracoscopic or pleural drainage by percutaneous drain associated with urokinase- congenital pulmonary disorders with lung function impairment
- congenital pulmonary disorders with lung function impairment
- chronic pulmonary disease associated with lung function impairment
- hemodynamic instability
- congenital immunodeficiency disease
- secondary immune deficiency induced
- hemostasis disorder (contraindication of thrombolytic therapy)
- pregnancy or breastfeeding patient
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Queen Fabiola University Children Hospital
Brussels, 1020
Nicolas Lefevre, MD, nicolas.lefevre@huderf.be
Nicolas Lefevre, MD
About this study
Official title: Prospective Randomized Study Comparing the Efficacy and Safety 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
Despite the improvement in the technology available for diagnosing and treating empyema, the management of empyema in children remains controversial.
The purpose of this study is to compare the efficacy and safety of two common technical approach used for pleural effusion drainage in the treatment of childhood empyema.
- Conditions
- Empyema, Pleural
- Being tested
- insertion of a chest drain with urokinase instillation, primary video-assisted thorascopic surgery
- Medical subject headings
- Empyema, Pleural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insertion of a chest drain with urokinase instillationDrug
Other interventions except drainage procedure are the same in both arms
primary video-assisted thorascopic surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Urokinase | Other | insertion of a chest drain with urokinase instillation Receives: Drug: insertion of a chest drain with urokinase instillation |
| VATS | Other | primary video-assisted thorascopic surgery Other interventions except drainage procedure are the same in both arms Receives: Procedure: primary video-assisted thorascopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of drainage
Measured: end of drainage defined per protocole as < 1ml/kg/24h with an expected average time of two days to seven days
Secondary outcomes (6)
length of hospital stay
Measured: Hospital departure with an expected average time of two weeks to one month
Duration of oxygen therapy
Measured: up to the end of patient hospitalisation with an expected average time of 48 hours to five days
duration of intravenous antibiotic therapy
Measured: up to the last intravenous antibiotic injection, minimum of 48 hours for a simple pleural effusion and a minimum of 14 days for an empyema with a maximum of one month
Duration of fever > 38.5°C
Measured: Up to fever resolution, with an average expected time of five days to 14 days
Number of Participants with Serious and Non-Serious Adverse Events
Measured: Up to the end of the hospitalisation, until three months corresponding to the end of follow up period
Patient discomfort
Measured: Up to chest drain removal with an average expected time of 48 hours up to seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startFeb 2015
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Empyema, PleuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165891
- Sponsor's protocol ID
- P2013/PE1
- Acronym
- UROVATS
- Status last verified
- Jul 2018
- First submitted
- 26 Feb 2014
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing the Efficacy and Safety 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
- ClinicalTrials.gov ID
- NCT02165891
- Acronym / sponsor ID
- UROVATS / P2013/PE1
- Conditions
- Empyema, Pleural
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the improvement in the technology available for diagnosing and treating empyema, the management of empyema in children remains controversial.
The purpose of this study is to compare the efficacy and safety of two common technical approach used for pleural effusion drainage in the treatment of childhood empyema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urokinase | Other | Drug: insertion of a chest drain with urokinase instillationinsertion of a chest drain with urokinase instillation |
| VATS | Other | Procedure: primary video-assisted thorascopic surgeryprimary video-assisted thorascopic surgery Other interventions except drainage procedure are the same in both arms |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- patients under the age of 17
- pleural fluid depth of at least 15mm, confirmed by ultrasound
- at least one of the following severity criteria :
Key exclusion criteria (8 listed)
- previous drainage by either Video-Assisted Thoracoscopic or pleural drainage by percutaneous drain associated with urokinase- congenital pulmonary disorders with lung function impairment
- congenital pulmonary disorders with lung function impairment
- chronic pulmonary disease associated with lung function impairment
- hemodynamic instability
- congenital immunodeficiency disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insertion of a chest drain with urokinase instillationOther interventions except drainage procedure are the same in both arms | Drug | Urokinase |
| primary video-assisted thorascopic surgery | Procedure or surgery | VATS |
Primary outcome
duration of drainage
Time frame: end of drainage defined per protocole as < 1ml/kg/24h with an expected average time of two days to seven days
6 secondary outcomes
length of hospital stay
Time frame: Hospital departure with an expected average time of two weeks to one month
Duration of oxygen therapy
Time frame: up to the end of patient hospitalisation with an expected average time of 48 hours to five days
duration of intravenous antibiotic therapy
Time frame: up to the last intravenous antibiotic injection, minimum of 48 hours for a simple pleural effusion and a minimum of 14 days for an empyema with a maximum of one month
Duration of fever > 38.5°C
Time frame: Up to fever resolution, with an average expected time of five days to 14 days
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: Up to the end of the hospitalisation, until three months corresponding to the end of follow up period
Patient discomfort
Time frame: Up to chest drain removal with an average expected time of 48 hours up to seven days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insertion of a chest drain with urokinase instillation and primary video-assisted thorascopic surgery in people with Empyema, Pleural, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of drainage (time frame: end of drainage defined per protocole as < 1ml/kg/24h with an expected average time of two days to seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.