Pleural EmpyemaPhase 2/3DUKENCT00502632
Dornase Alfa and Urokinase for Kids With Pleural Empyema
A Phase 2/3 study testing Urokinase and Dornase alfa and Urokinase in people with Pleural Empyema, run by Azienda Ospedaliera di Padova at 3 sites in Italy.
Trial summary
The purpose of this study is to determine whether intrapleural treatment with Dornase alfa plus Urokinase improves clinical outcome compared to Urokinase alone in children with complicated parapneumonic effusions Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Pleural Empyema
- What is being tested?
- Urokinase and Dornase alfa and Urokinase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 3 sitesItaly
- Study dates
- Oct 2007to Oct 2009
- Phase
- Phase 2/3
- 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
- Age > 1 year and < 16 years
- Respiratory infection (pneumonia or lung abscess)
- Effusion occupying at least 1/3 of hemithorax on chest X-ray
- Complicated effusion (presence of at least one of the following):
- Hyperechoic pleural fluid on chest US scan
- Loculated collection on chest US or CT scan
- Purulent pleural fluid
- Positive culture or Gram stain on pleural fluid
Who cannot join
- Non parapneumonic effusion
- Immunodeficiency
- Neurological impairment
- Suspected or proven allergy to Urokinase or Dornase alfa
- Suspected or documented bronchopleural fistula
- Impaired coagulation (INR>2), haemorrhage, high risk for bleeding
- Thoracic surgical procedure (e.g. thoracoscopy, mini-thoracotomy) already performed
- Chest drain inserted since 6 or more days
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
Ospedali Riuniti di Bergamo
Bergamo, 24128
Maurizio Cheli, MD, mauriziocheli@tin.it
Maurizio Cheli, MD
- Recruiting
Azienda Ospedaliera di Padova
Padova, 35128
PierGiorgio Gamba, MD, +39 049 821 3683, piergiorgio.gamba@unipd.it
Eleonora Cesca, MD
- Recruiting
Ospedale Bambino Gesu'
Roma, 00165
Alessandro Inserra, MD, +39 06 6859 2423, lobina@opbg.net
Alessandro Inserra, MD
About this study
Official title: Multicentre Randomized Double-Blinded Trial of Intrapleural Dornase Alfa and Urokinase vs Urokinase Alone for Complicated Parapneumonic Effusions in Children
The purpose of this study is to determine whether intrapleural treatment with Dornase alfa plus Urokinase improves clinical outcome compared to Urokinase alone in children with complicated parapneumonic effusions
- Conditions
- Pleural Empyema
- Being tested
- Urokinase and Dornase alfa, Urokinase
- Keywords
- Pleural empyema, Pleural effusion, Dornase alfa, Urokinase, Children
- Medical subject headings
- Empyema, Pleural, Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urokinase and Dornase alfaDrug
Intrapleural administration of:
- Urokinase 40,000 in 40ml normal saline, twice daily for 4 days
- Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days
UrokinaseDrug
Intrapleural administration of:
- Urokinase 40,000 in 40ml normal saline, twice daily for 4 days
- 25ml normal saline, twice daily for 4 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intrapleural administration of:
* Urokinase 40,000 in 40ml normal saline, twice daily for 4 days
* Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days Receives: Drug: Urokinase and Dornase alfa |
| 2 | Placebo comparator | Intrapleural administration of:
* Urokinase 40,000 in 40ml normal saline, twice daily for 4 days
* 25ml normal saline, twice daily for 4 days Receives: Drug: Urokinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospital stay
Measured: From beginning of intrapleural treatment
Need for additional surgical procedures
Measured: 3 months
Secondary outcomes (3)
Duration of suction applied to chest drain
Measured: From beginning of intrapleural treatment
Duration of fever
Measured: From beginning of intrapleural treatment
Duration of intravenous antibiotic treatment
Measured: From beginning of intrapleural treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startOct 2007
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- PierGiorgio Gamba, MD, Study chair, Azienda Ospedaliera di PadovaGiorgio Stefanutti, MD, Principal investigator, Women's and Children's Hospital, Adelaide, SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502632
- Sponsor's protocol ID
- 1372P
- Acronym
- DUKE
- Status last verified
- May 2008
- First submitted
- 16 Jul 2007
- Last updated
- 12 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomized Double-Blinded Trial of Intrapleural Dornase Alfa and Urokinase vs Urokinase Alone for Complicated Parapneumonic Effusions in Children
- ClinicalTrials.gov ID
- NCT00502632
- Acronym / sponsor ID
- DUKE / 1372P
- Conditions
- Pleural Empyema
- Keywords
- Pleural empyema, Pleural effusion, Dornase alfa, Urokinase, Children
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Oct 2007
- Study completion
- Oct 2009 (estimated)
- First posted
- 17 Jul 2007 (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.
The purpose of this study is to determine whether intrapleural treatment with Dornase alfa plus Urokinase improves clinical outcome compared to Urokinase alone in children with complicated parapneumonic effusions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Urokinase and Dornase alfaIntrapleural administration of: * Urokinase 40,000 in 40ml normal saline, twice daily for 4 days * Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days |
| 2 | Placebo comparator | Drug: UrokinaseIntrapleural administration of: * Urokinase 40,000 in 40ml normal saline, twice daily for 4 days * 25ml normal saline, twice daily for 4 days |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age > 1 year and < 16 years
- Respiratory infection (pneumonia or lung abscess)
- Effusion occupying at least 1/3 of hemithorax on chest X-ray
- Complicated effusion (presence of at least one of the following):
Key exclusion criteria (8 listed)
- Non parapneumonic effusion
- Immunodeficiency
- Neurological impairment
- Suspected or proven allergy to Urokinase or Dornase alfa
- Suspected or documented bronchopleural fistula
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 |
|---|---|---|
| Urokinase and Dornase alfaIntrapleural administration of: * Urokinase 40,000 in 40ml normal saline, twice daily for 4 days * Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days | Drug | 1 |
| UrokinaseIntrapleural administration of: * Urokinase 40,000 in 40ml normal saline, twice daily for 4 days * 25ml normal saline, twice daily for 4 days | Drug | 2 |
Primary outcome
Duration of hospital stay
Time frame: From beginning of intrapleural treatment
Need for additional surgical procedures
Time frame: 3 months
3 secondary outcomes
Duration of suction applied to chest drain
Time frame: From beginning of intrapleural treatment
Duration of fever
Time frame: From beginning of intrapleural treatment
Duration of intravenous antibiotic treatment
Time frame: From beginning of intrapleural treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2008.
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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.
PierGiorgio Gamba, MD study chair
Azienda Ospedaliera di Padova
Giorgio Stefanutti, MD principal investigator
Women's and Children's Hospital, Adelaide, SA
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Urokinase and Dornase alfa and Urokinase in people with Pleural Empyema, run by Azienda Ospedaliera di Padova at 3 sites in Italy.
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 8 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 12 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact PierGiorgio Gamba, MD (+39 049 821 3683, piergiorgio.gamba@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospital stay (time frame: From beginning of intrapleural treatment). The study lists 2 primary outcomes in all. 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 12 May 2008.