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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01717742
Other study ID # 1000033767
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date December 2012
Est. completion date December 2017

Study information

Verified date April 2020
Source The Hospital for Sick Children
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 6 Months to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TPA (Tissue Plasminogen Activator)
Intrapleural administration of tPA 4 mg in 10 ml (=10 kg) or 20 ml (>10 kg) normal saline once daily for 3 days
DNase
Intrapleural administration of DNase 5 mg diluted to 10 ml (=10 kg) or 20 ml (>10 kg) normal saline once daily for 3 days
Other:
Placebo
Intrapleural administration of normal saline 10 ml (=10 kg) or 20 ml (>10 kg)

Locations

Country Name City State
Canada Alberta Children's Hospital Calgary Alberta
Canada McMaster Children's Hospital Hamilton Ontario
Canada CHU Sainte Justine Montreal Quebec
Canada Children's Hospital of Eastern Ontario Ottawa Ontario
Canada The Hospital for Sick Children(SickKids) Toronto Ontario
Canada British Columbia Children's Hospital Vancouver British Columbia

Sponsors (8)

Lead Sponsor Collaborator
The Hospital for Sick Children 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

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Livingston MH, Mahant S, Connolly B, MacLusky I, Laberge S, Giglia L, Yang C, Roberts A, Shawyer A, Brindle M, Parsons S, Stoian C, Walton JM, Thorpe KE, Chen Y, Zuo F, Mamdani M, Chan C, Loong D, Isaranuwatchai W, Ratjen F, Cohen E. Effectiveness of Intr — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Chest Radiography The radiograph closest to the time of drain removal will be reviewed by a blinded study radiologist to determine the percentage of hemithorax occupied using a 5 point ordinal scale utilized in previous studies ranging from no fluid present to fluid occupying >75% of the most affected hemithorax. 7 days after drain removal
Primary Time to Hospital Discharge Time from insertion of the chest drain to discharge from hospital. up to 4 months
Secondary Time to Meeting Discharge Criteria Time from insertion of the chest drain to meeting discharge criteria.
Discharge criteria:
Chest tube removed
No fever [temperature less than 38°C]
Normal respiratory rate forage
No hypoxia
Drinking fluids wel
up to 4 months
Secondary Time to Drain Removal Time from drain insertion to drain removal. up to 4 months
Secondary Duration of Fever After Intervention Duration of fever (defined as temperature >38 degrees celsius taken by any method) from insertion of the chest drain until resolution. up to 4 months
Secondary Number of Participants With Need for Ventilatory Support or Non-invasive Ventilation Following the Intervention Number of Participants with need for any kind of ventilatory support or any kind of non-invasive ventilation right after the intervention. up to 4 months
Secondary Number of Participants With Serious Bleeding Number of Participants who had intrapleural bleeding resulting in a drop in hemoglobin of greater than 20 g/L or needing a transfusion. up to 4 months
Secondary Number of Participants With Further Interventions Number of participants who needed 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. up to 4 months
Secondary Number of Participants With Hospital Readmission Number of Participants who had any hospital readmission after discharge from hospital for initial treatment for pleural empyema within three months related to pleural empyema or its treatment. 3 months post-discharge
Secondary Cost of the Hospitalization 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. up to 4 months
Secondary Mortality Mortality from any cause during the hospitalization for empyema. up to 4 months
See also
  Status Clinical Trial Phase
Recruiting NCT04095676 - VATS Surgery Compared to Drainage in the Treatment of Pleural Empyema N/A
Completed NCT01011881 - Procalcitonin in Pleural Pleuritis N/A
Recruiting NCT00502632 - Dornase Alfa and Urokinase for Kids With Pleural Empyema Phase 2/Phase 3
Terminated NCT00234208 - Early Medical Thoracoscopy Versus Simple Chest Tube Drainage in Complicated Parapneumonic Effusion and Pleural Empyema Phase 3
Active, not recruiting NCT05077111 - A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia Phase 4