EmpyemaPhase 3NCT00798278
Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood
A Phase 3 study testing Urokinase and Video-Assisted Thoracoscopic in people with Empyema and Pneumonia, run by Spanish Society of Pediatric Surgery at 6 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- What is being tested?
- Urokinase and Video-Assisted Thoracoscopic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 6 sitesSpain
- Study dates
- Jul 2008to Sep 2010
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Existing contraindications or other previous conditions, hypertension, pneumothorax
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
University Hospital Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Gregorio Marañón
Madrid, Madrid
Hospital Infantil La Paz
Madrid, Madrid
Hospital Universitario 12 de Octubre
Madrid, Madrid
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias
Hospital de Donostia
San Sebastián, Donostia, 20014
About this study
Official title: Exploratory Multicentre Clinical Trial to Compare the Efficacy of Urokinase Versus Video-assisted Thoracoscopic for Treatment of Complicated Parapneumonic Empyema in Childhood
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).
- Being tested
- Urokinase, Video-Assisted Thoracoscopic
- Keywords
- Empyema, Urokinase, Thoracoscopic, Childhood
- Medical subject headings
- Empyema, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrokinaseDrug
Chest tube with intrapleural urokinase infusion for 3 days
Video-Assisted ThoracoscopicProcedure or surgery
Video-Assisted Thoracoscopic decortication
| Study group | Role | What they receive |
|---|---|---|
| Urokinase | Experimental | urokinase infusion for 3 days Receives: Drug: Urokinase |
| Thoracoscopic | Active comparator | Video-Assisted Thoracoscopic Receives: Procedure: Video-Assisted Thoracoscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of the hospital stay after the treatment
Measured: 3 months
Secondary outcomes (4)
complications of the treatment and complications of the disease
Measured: 3 months
total duration of the hospital stay
Measured: 3 months
number of days carrying the chest drain
Measured: 3 months
duration of the fever once the empyema has been drained
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmpyemaStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spanish Society of Pediatric Surgery
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798278
- Sponsor's protocol ID
- UKVATS2007
- Other IDs
- EudraCT Number 2007-003416-61
- Status last verified
- Nov 2008
- First submitted
- 25 Nov 2008
- Last updated
- 28 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Multicentre Clinical Trial to Compare the Efficacy of Urokinase Versus Video-assisted Thoracoscopic for Treatment of Complicated Parapneumonic Empyema in Childhood
- ClinicalTrials.gov ID
- NCT00798278
- Acronym / sponsor ID
- UKVATS2007
- Keywords
- Empyema, Urokinase, Thoracoscopic, Childhood
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Spanish Society of Pediatric SurgeryUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 26 Nov 2008 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urokinase | Experimental | Drug: Urokinaseurokinase infusion for 3 days |
| Thoracoscopic | Active comparator | Procedure: Video-Assisted ThoracoscopicVideo-Assisted Thoracoscopic |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Existing contraindications or other previous conditions, hypertension, pneumothorax
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 |
|---|---|---|
| UrokinaseChest tube with intrapleural urokinase infusion for 3 days | Drug | Urokinase |
| Video-Assisted ThoracoscopicVideo-Assisted Thoracoscopic decortication | Procedure or surgery | Thoracoscopic |
Primary outcome
duration of the hospital stay after the treatment
Time frame: 3 months
4 secondary outcomes
complications of the treatment and complications of the disease
Time frame: 3 months
total duration of the hospital stay
Time frame: 3 months
number of days carrying the chest drain
Time frame: 3 months
duration of the fever once the empyema has been drained
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Urokinase and Video-Assisted Thoracoscopic in people with Empyema and Pneumonia, run by Spanish Society of Pediatric Surgery at 6 sites in Spain.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of the hospital stay after the treatment (time frame: 3 months). 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 28 Oct 2010.