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Pleural EmpyemaPhase 3NCT01717742

Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial)

A Phase 3 study testing TPA (Tissue Plasminogen Activator) and DNase in people with Pleural Empyema, run by The Hospital for Sick Children at 6 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Bacterial pneumonia can be complicated by the development of excess fluid and pus (pleural empyema) around the lungs in children. The incidence of pleural empyema in children has increased significantly in the last 10 years. Read more about this study

Who is it for?
Ages 6 months to 18 years
Conditions the study is for
Pleural Empyema
What is being tested?
TPA (Tissue Plasminogen Activator) and DNase
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
97 participants
Where
6 sitesCanada
Study dates
Dec 2012to Dec 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 6 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • age 6 months to 18 years
  • hospitalized with diagnosis of pleural empyema requiring chest tube drainage with fibrinolytics as judged by the attending physician with the following criteria:
  • pneumonia with pleural effusion as documented on ultrasound of the chest; AND
  • need for further intervention in addition to antibiotics based on clinical criteria [persistent fever despite on antibiotics for at least 48 hours OR significant respiratory distress tachypnea, hypoxia) as a result of the pleural fluid collection]

Who cannot join

  • empyema as a result of tuberculosis, fungus or non-infectious causes (e.g. malignancy)
  • known coagulation impairment
  • suspected or proven allergy to tPA or DNase
  • chronic lung disease or other chronic illnesses (e.g. immunodeficiency or neurologic impairment)
  • child has already undergone a drainage procedure (e.g. chest drain or VATS).
  • recent administration of an investigational drug (within previous 30 days)
  • pregnancy
  • breastfeeding

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • Alberta Children's Hospital

    Calgary, Alberta

  • McMaster Children's Hospital

    Hamilton, Ontario, L8N 3Z5

  • CHU Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • The Hospital for Sick Children(SickKids)

    Toronto, Ontario, M5G 1X8

  • British Columbia Children's Hospital

    Vancouver, British Columbia, BC V6H 3N1

Other trials in Canada

About this study

Bacterial pneumonia can be complicated by the development of excess fluid and pus (pleural empyema) around the lungs in children. The incidence of pleural empyema in children has increased significantly in the last 10 years.

Short term morbidity for this condition is substantial, but unlike in adults, the long term outcome of this condition for children in developed countries is favourable. Inserting a chest drain and then adding a medicine (tissue plasminogen activator - tPA) to break down organized pus has been shown to be an effective therapy for reducing the duration of illness. However, this treatment is still suboptimal and prolonged hospitalization is common. Recent data from adults suggests that adding an additional medicine (DNase) to decrease the viscosity (thickness) of the fluid improves drainage and leads to better patient outcomes; however, there are no published studies on children.

This is a multi-centre randomized controlled trial comparing the time to discharge from hospital after chest drain insertion in previously well children who present with pleural empyema, treated with intrapleural DNase and tissue plasminogen activator (tPA) by chest drain for three doses over 48 hours compared with three doses over 48 hours of tPA alone. Other outcomes related to effectiveness, safety and cost will be assessed as well.

Conditions
Pleural Empyema
Being tested
TPA (Tissue Plasminogen Activator), DNase, Placebo
Keywords
Randomized controlled trial, Pleural Empyema, tPA, DNase
Medical subject headings
Empyema, Pleural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TPA (Tissue Plasminogen Activator)Drug

    Also called Cathflo (alteplase, recombinant)

    Intrapleural administration of tPA 4 mg in 10 ml (≤10 kg) or 20 ml (>10 kg) normal saline once daily for 3 days

  • DNaseDrug

    Also called Pulmozyme (Dornase alfa)

    Intrapleural administration of DNase 5 mg diluted to 10 ml (≤10 kg) or 20 ml (>10 kg) normal saline once daily for 3 days

  • PlaceboOther

    Also called Normal saline

    Intrapleural administration of normal saline 10 ml (≤10 kg) or 20 ml (>10 kg)

Study groups in NCT01717742
Study groupRoleWhat they receive
tPA and placeboActive comparatorNot described
Receives: Drug: TPA (Tissue Plasminogen Activator); Other: Placebo
tPA and DNaseExperimentalNot described
Receives: Drug: TPA (Tissue Plasminogen Activator); Drug: DNase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Hospital Discharge

    Time from insertion of the chest drain to discharge from hospital.

    Measured: up to 4 months

Secondary outcomes (9)

  1. Time to Meeting Discharge Criteria

    Time from insertion of the chest drain to meeting discharge criteria.

    Discharge criteria:

    • Chest tube removed
    • No fever [temperature less than 38°C]
    • Normal respiratory rate forage
    • No hypoxia
    • Drinking fluids wel

    Measured: up to 4 months

  2. Time to Drain Removal

    Time from drain insertion to drain removal.

    Measured: up to 4 months

  3. Duration of Fever After Intervention

    Duration of fever (defined as temperature >38 degrees celsius taken by any method) from insertion of the chest drain until resolution.

    Measured: up to 4 months

  4. Number of Participants With Need for Ventilatory Support or Non-invasive Ventilation Following the Intervention

    Number of Participants with need for any kind of ventilatory support or any kind of non-invasive ventilation right after the intervention.

    Measured: up to 4 months

  5. Number of Participants With Serious Bleeding

    Number of Participants who had intrapleural bleeding resulting in a drop in hemoglobin of greater than 20 g/L or needing a transfusion.

    Measured: up to 4 months

  6. Number of Participants With Further Interventions

    Number of participants who needed further intervention such as placement of another chest drain (by any technique) or surgical intervention such as thoracotomy and decortication, video-assisted thorascopic surgery, or pneumonectomy.

    Measured: up to 4 months

  7. Number of Participants With Hospital Readmission

    Number of Participants who had any hospital readmission after discharge from hospital for initial treatment for pleural empyema within three months related to pleural empyema or its treatment.

    Measured: 3 months post-discharge

  8. Cost of the Hospitalization

    An economic evaluation will compare the relative costs of DNase-tPA with tPA alone in previously well children who present with pleural empyema, using patient-level data from the trial.

    Measured: up to 4 months

  9. Mortality

    Mortality from any cause during the hospitalization for empyema.

    Measured: up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01717742
Sponsor's protocol ID
1000033767
Status last verified
Apr 2020
First submitted
25 Oct 2012
Last updated
14 Apr 2020
Data monitoring committee
Yes

Publications

  • Livingston MH, Mahant S, Connolly B, MacLusky I, Laberge S, Giglia L, Yang C, Roberts A, Shawyer A, Brindle M, Parsons S, Stoian C, Walton JM, Thorpe KE, Chen Y, Zuo F, Mamdani M, Chan C, Loong D, Isaranuwatchai W, Ratjen F, Cohen E. Effectiveness of Intrapleural Tissue Plasminogen Activator and Dornase Alfa vs Tissue Plasminogen Activator Alone in Children with Pleural Empyema: A Randomized Clinical Trial. JAMA Pediatr. 2020 Apr 1;174(4):332-340. doi: 10.1001/jamapediatrics.2019.5863.

    PubMed 32011642

  • Livingston MH, Mahant S, Ratjen F, Connolly BL, Thorpe K, Mamdani M, Maclusky I, Laberge S, Giglia L, Walton JM, Yang CL, Roberts A, Shawyer AC, Brindle M, Parsons SJ, Stoian CA, Cohen E. Intrapleural Dornase and Tissue Plasminogen Activator in pediatric empyema (DTPA): a study protocol for a randomized controlled trial. Trials. 2017 Jun 24;18(1):293. doi: 10.1186/s13063-017-2026-0.

    PubMed 28646887

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TPA (Tissue Plasminogen Activator) and DNase in people with Pleural Empyema, run by The Hospital for Sick Children at 6 sites in Canada.

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 4 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: finished, as of the sponsor's last update on 14 Apr 2020. 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 Canada. 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?

Yes. Results are posted in the registry (first posted 3 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Time to Hospital Discharge (time frame: up to 4 months). 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 NCT01717742, which also lists 2 linked publications.

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 14 Apr 2020.

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