EmpyemaPhase 1NCT00144950
Urokinase Versus Primary Video-Assisted Thorascopic Surgery for Empyema
A Phase 1 study testing insertion of a chest drain with urokinase instillation and primary video-assisted thorascopic surgery in people with Empyema, run by Institute of Child Health at 1 site in United Kingdom.
Trial summary
This study will compare VATS versus chest drain insertion and urokinase in the treatment of childhood empema by a randomised prospective study. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Empyema
- What is being tested?
- insertion of a chest drain with urokinase instillation and primary video-assisted thorascopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients under the age of 16 referred to GOSH for management of empyema
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This study will compare VATS versus chest drain insertion and urokinase in the treatment of childhood empema by a randomised prospective study.
- Conditions
- Empyema
- Being tested
- insertion of a chest drain with urokinase instillation, primary video-assisted thorascopic surgery
- Medical subject headings
- Empyema
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
primary video-assisted thorascopic surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
length of hospital stay
Secondary outcomes (1)
radiological changes at follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Institute of Child Health
- Sponsor type
- University, hospital or other
- Investigators
- Adam Jaffe, Dr, Principal investigator, Great Ormond Street Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144950
- Sponsor's protocol ID
- 02AR04
- Status last verified
- Sep 2005
- First submitted
- 2 Sep 2005
- Last updated
- 5 Sep 2005
- Results posted
- No
Publications
Jaffe A, Calder AD, Owens CM, Stanojevic S, Sonnappa S. Role of routine computed tomography in paediatric pleural empyema. Thorax. 2008 Oct;63(10):897-902. doi: 10.1136/thx.2007.094250. Epub 2008 May 20.
PubMed 18492739
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urokinase Versus Primary Video-Assisted Thorascopic Surgery for Empyema
- ClinicalTrials.gov ID
- NCT00144950
- Acronym / sponsor ID
- 02AR04
- Conditions
- Empyema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Institute of Child HealthUniversity, hospital or other
- First posted
- 5 Sep 2005 (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.
This study will compare VATS versus chest drain insertion and urokinase in the treatment of childhood empema by a randomised prospective study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- patients under the age of 16 referred to GOSH for management of empyema
Key exclusion criteria (1 listed)
- -
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 instillation | Drug | – |
| primary video-assisted thorascopic surgery | Procedure or surgery | – |
Primary outcome
length of hospital stay
1 secondary outcome
radiological changes at follow up
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 5 Sep 2005.
- Derived from this study: PubMed 18492739Jaffe A, Calder AD, Owens CM, Stanojevic S, Sonnappa S. Role of routine computed tomography in paediatric pleural empyema. Thorax. 2008 Oct;63(10):897-902. doi: 10.1136/thx.2007.094250. Epub 2008 May 20.
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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.
Adam Jaffe, Dr principal investigator
Great Ormond Street Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing insertion of a chest drain with urokinase instillation and primary video-assisted thorascopic surgery in people with Empyema, run by Institute of Child Health at 1 site in United Kingdom.
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 5 Sep 2005. 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 United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
length of hospital stay. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00144950, which also lists 1 linked publication.
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 Sep 2005.