Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial)
Information source: The Hospital for Sick Children
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pleural Empyema
Intervention: tPA (Drug); DNase (Drug); Placebo (Other)
Phase: Phase 3
Status: Recruiting
Sponsored by: The Hospital for Sick Children Official(s) and/or principal investigator(s): Eyal Cohen, MD, MSc, Principal Investigator, Affiliation: The Hospital for Sick Children
Overall contact: Eyal cohen, MD, MSc, Phone: 416-813-5795, Email: eyal.cohen@sickkids.ca
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.
Clinical Details
Official title: Intrapleural DNase and Tissue Plasminogen Activator in Pediatric Empyema (DTPA Trial)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Time to hospital discharge
Secondary outcome: Time to meeting discharge criteriaTime to drain removal Duration of fever after intervention Need for ventilatory support or non-invasive ventilation following the intervention Serious bleeding Need for further interventions Hospital readmission Cost of the hospitalization Mortality
Eligibility
Minimum age: 6 Months.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. age 6 months to 18 years
2. hospitalized with diagnosis of pleural empyema requiring chest tube drainage with
fibrinolytics as judged by the attending physician with the following criteria:
1. pneumonia with pleural effusion as documented on ultrasound of the chest; AND
2. 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]
Exclusion Criteria:
1. empyema as a result of tuberculosis, fungus or non-infectious causes (e. g.
malignancy)
2. known coagulation impairment
3. suspected or proven allergy to tPA or DNase
4. chronic lung disease or other chronic illnesses (e. g. immunodeficiency or neurologic
impairment)
5. child has already undergone a drainage procedure (e. g. chest drain or VATS).
6. recent administration of an investigational drug (within previous 30 days)
7. pregnancy
8. breastfeeding
Locations and Contacts
Eyal cohen, MD, MSc, Phone: 416-813-5795, Email: eyal.cohen@sickkids.ca
British Columbia Children's Hospital, Vancouver, British Columbia BC V6H 3N1, Canada; Recruiting Connie Yang, MD, Phone: 604-875-2000, Ext: 4931, Email: connie.yang@cw.bc.ca Connie Yang, MD, Sub-Investigator
McMaster Children's Hospital, Hamilton, Ontario L8N 3Z5, Canada; Recruiting Lucy Giglia, MD, Phone: (905) 523-6766, Email: giglial@mcmaster.ca Mark Walton, MD, Phone: 905-525-9140, Ext: 22116, Email: waltonj@mcmaster.ca Lucy Giglia, MD, Sub-Investigator Mark Walton, MD, Sub-Investigator
Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H 8L1, Canada; Recruiting Ian Maclusky, MD, Phone: 613-737-7600 Ian Maclusky, MD, Sub-Investigator
The Hospital for Sick Children(SickKids), Toronto, Ontario M5G 1X8, Canada; Recruiting Eyal Cohen, MD, MSc, Phone: 416-813-5795, Email: eyal.cohen@sickkids.ca Sanjay Mahant, MD, MSc, Phone: 416-813-8422, Email: sanjay.mahant@sickkids.ca Eyal Cohen, MD, MSc, Principal Investigator Sanjay Mahant, MD, MSc, Sub-Investigator Felix Ratjen, MD, Sub-Investigator Bairbre Connolly, MD, Sub-Investigator
CHU Sainte Justine, Montreal, Quebec H3T 1C5, Canada; Recruiting Sophie Laberge, MD, Phone: 514-345-4931, Ext: 5409, Email: sophie.laberge@umontreal.ca Sophie Laberge, MD, Sub-Investigator
Additional Information
Starting date: December 2012
Last updated: May 19, 2015
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