DUKE: Dornase Alfa and Urokinase for Kids With Pleural Empyema

Sponsor

Azienda Ospedaliera di Padova (Other)

Overall Status

Unknown status

CT.gov ID

NCT00502632

Collaborator

Hoffmann-La Roche (Industry)

Enrollment

Locations

Arms

Duration (Months)

31.3

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether intrapleural treatment with Dornase alfa plus Urokinase improves clinical outcome compared to Urokinase alone in children with complicated parapneumonic effusions

Condition or Disease	Intervention/Treatment	Phase
Pleural Empyema	Drug: Urokinase and Dornase alfa Drug: Urokinase	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Multicentre Randomized Double-Blinded Trial of Intrapleural Dornase Alfa and Urokinase vs Urokinase Alone for Complicated Parapneumonic Effusions in Children

Study Start Date :

Oct 1, 2007

Anticipated Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days	Drug: Urokinase and Dornase alfa Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days
Placebo Comparator: 2 Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days 25ml normal saline, twice daily for 4 days	Drug: Urokinase Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days 25ml normal saline, twice daily for 4 days

Arm

Intervention/Treatment

Experimental: 1

Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days

Drug: Urokinase and Dornase alfa

Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days Dornase alfa 2,500 IU in 25ml normal saline, twice daily for 4 days

Placebo Comparator: 2

Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days 25ml normal saline, twice daily for 4 days

Drug: Urokinase

Intrapleural administration of: Urokinase 40,000 in 40ml normal saline, twice daily for 4 days 25ml normal saline, twice daily for 4 days

Outcome Measures

Primary Outcome Measures

Duration of hospital stay [From beginning of intrapleural treatment]
Need for additional surgical procedures [3 months]

Secondary Outcome Measures

Duration of suction applied to chest drain [From beginning of intrapleural treatment]
Duration of fever [From beginning of intrapleural treatment]
Duration of intravenous antibiotic treatment [From beginning of intrapleural treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age > 1 year and < 16 years
Respiratory infection (pneumonia or lung abscess)
Effusion occupying at least 1/3 of hemithorax on chest X-ray
Complicated effusion (presence of at least one of the following):
Hyperechoic pleural fluid on chest US scan
Loculated collection on chest US or CT scan
Purulent pleural fluid
Positive culture or Gram stain on pleural fluid

Exclusion Criteria:

Non parapneumonic effusion
Immunodeficiency
Neurological impairment
Suspected or proven allergy to Urokinase or Dornase alfa
Suspected or documented bronchopleural fistula
Impaired coagulation (INR>2), haemorrhage, high risk for bleeding
Thoracic surgical procedure (e.g. thoracoscopy, mini-thoracotomy) already performed
Chest drain inserted since 6 or more days

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Ospedali Riuniti di Bergamo	Bergamo	Italy	24128
2	Azienda Ospedaliera di Padova	Padova	Italy	35128
3	Ospedale Bambino Gesu'	Roma	Italy	00165

Sponsors and Collaborators

Azienda Ospedaliera di Padova
Hoffmann-La Roche

Investigators

Study Chair: PierGiorgio Gamba, MD, Azienda Ospedaliera di Padova
Principal Investigator: Giorgio Stefanutti, MD, Women's and Children's Hospital, Adelaide, SA