CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 97 enrolled
Drug / intervention
TPA (Tissue Plasminogen Activator) +2 moredrug
Likely dose
TPA (Tissue Plasminogen Activator) 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01717742
NCT01717742Phase 3Completed

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

The Hospital for Sick Children·interventional·Posted Oct 30, 2012·Updated Apr 14, 2020

In Brief

A Phase 3 clinical trial evaluating TPA (Tissue Plasminogen Activator), DNase, and 1 other intervention for Pleural Empyema. Completed, enrolled 97 participants across 6 sites.

Detailed 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.

Study Details

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 30, 2012
Enrollment StartDec 1, 2012
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 13.7 years ago

Interventions

TPA (Tissue Plasminogen Activator)drug

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

DNasedrug

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

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