EmpyemaPhase 3NCT01862458
Empyema Treated With tPA & DNAse
A Phase 3 study testing tPA alone and tPA plus dornase in people with Empyema, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The objective of this study is to scientifically evaluate a new substrate for fibrinolysis compared to our standard tPA. The hypothesis, driven by a recent prospective trial, is that tPA may benefit from the addition of DNAse. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Empyema
- What is being tested?
- tPA alone and tPA plus dornase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2016
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients less than 18 years of age requiring an intervention for empyema by one of the following:
- Septation or loculation seen on ultrasound or computed tomography or
- Greater than 10,000 white blood cells identified on pleural tap
Who cannot join
- Immunodeficiency process
- Secondary diagnosis or condition that will keep them in the hospital beyond the empyema
- Existing contraindications to chest tube
- Documented allergy to one of the study medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Prospective Randomized Trial: Fibrinolysis With tPA (Tissue Plasminogen Activator) Versus tPA and DNAse in Children With Empyema
The objective of this study is to scientifically evaluate a new substrate for fibrinolysis compared to our standard tPA.
The hypothesis, driven by a recent prospective trial, is that tPA may benefit from the addition of DNAse.
The primary outcome variable between the two techniques will be length of hospitalization after initiation of treatment.
- Conditions
- Empyema
- Being tested
- tPA alone, tPA plus dornase
- Keywords
- empyema, tPA, dornase
- Medical subject headings
- Empyema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tPA aloneBiological
tPA plus dornaseBiological
| Study group | Role | What they receive |
|---|---|---|
| tPA alone | Active comparator | tPA alone used to treat empyema Receives: Biological: tPA alone |
| tPA plus dornase | Experimental | tPA plus dornase used to treat empyema Receives: Biological: tPA plus dornase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startJan 2016
- Primary completionJan 2016
- Study completionJan 2016
Why it stopped: funding difficulty
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shawn St. Peter, Children's Mercy Hospital Kansas City
- Investigators
- Shawn D St. Peter, MD, Principal investigator, Children's Mercy Hospital and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862458
- Sponsor's protocol ID
- 12120552
- Other IDs
- 12120552
- Status last verified
- Jan 2016
- First submitted
- 17 May 2013
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial: Fibrinolysis With tPA (Tissue Plasminogen Activator) Versus tPA and DNAse in Children With Empyema
- ClinicalTrials.gov ID
- NCT01862458
- Acronym / sponsor ID
- 12120552
- Conditions
- Empyema
- Keywords
- empyema, tPA, dornase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding difficulty
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 24 May 2013 (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 objective of this study is to scientifically evaluate a new substrate for fibrinolysis compared to our standard tPA.
The hypothesis, driven by a recent prospective trial, is that tPA may benefit from the addition of DNAse.
The primary outcome variable between the two techniques will be length of hospitalization after initiation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tPA alone | Active comparator | Biological: tPA alonetPA alone used to treat empyema |
| tPA plus dornase | Experimental | Biological: tPA plus dornasetPA plus dornase used to treat empyema |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients less than 18 years of age requiring an intervention for empyema by one of the following:
- Septation or loculation seen on ultrasound or computed tomography or
- Greater than 10,000 white blood cells identified on pleural tap
Key exclusion criteria (4 listed)
- Immunodeficiency process
- Secondary diagnosis or condition that will keep them in the hospital beyond the empyema
- Existing contraindications to chest tube
- Documented allergy to one of the study medications
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 |
|---|---|---|
| tPA alone | Biological | tPA alone |
| tPA plus dornase | Biological | tPA plus dornase |
Primary outcome
Length of stay
Time frame: 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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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.
Shawn D St. Peter, MD principal investigator
Children's Mercy Hospital and Clinics
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 tPA alone and tPA plus dornase in people with Empyema, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 28 Jan 2016. 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 States. 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 was withdrawn before enrolling participants, so there are no results.
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 stay (time frame: 3 weeks). 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 Jan 2016.