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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

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.


Detailed Summary:
Sponsor: The Hospital for Sick Children

Current Primary Outcome: Time to hospital discharge [ Time Frame: up to 4 months ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to meeting discharge criteria [ Time Frame: up to 4 months ]
    Time from insertion of the chest drain to meeting discharge criteria.
  • Time to drain removal [ Time Frame: up to 4 months ]
    Time from drain insertion to drain removal.
  • Duration of fever after intervention [ Time Frame: up to 4 months ]
    Duration of fever (defined as temperature >38 degrees celsius taken by any method) from insertion of the chest drain until resolution.
  • Need for ventilatory support or non-invasive ventilation following the intervention [ Time Frame: up to 4 months ]
    Need for any kind of ventilatory support or any kind of non-invasive ventilation right after the intervention.
  • Serious bleeding [ Time Frame: up to 4 months ]
    Intrapleural bleeding resulting in a drop in hemoglobin of greater than 20 g/L or needing a transfusion.
  • Need for further interventions [ Time Frame: up to 4 months ]
    Need for 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.
  • Hospital readmission [ Time Frame: 3 months post-discharge ]
    Any hospital readmission after discharge from hospital for initial treatment for pleural empyema within three months related to pleural empyema or its treatment.
  • Cost of the hospitalization [ Time Frame: up to 4 months ]
    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.
  • Mortality [ Time Frame: up to 4 months ]
    Mortality from any cause during the hospitalization for empyema.


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: October 25, 2012
Date Started: December 2012
Date Completion: December 2017
Last Updated: February 13, 2017
Last Verified: February 2017