Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial)
Status:
Completed
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
The Hospital for Sick Children
Collaborators:
British Columbia Children's Hospital Canadian Institutes of Health Research (CIHR) Children's Hospital of Eastern Ontario McMaster Children's Hospital St. Justine's Hospital St. Michael's Hospital, Toronto The Physicians' Services Incorporated Foundation Unity Health Toronto