DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 criteria

Time 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017