Dornase Alfa and Urokinase for Kids With Pleural Empyema - Full Text View

Sponsor:	Azienda Ospedaliera di Padova
Collaborator:	Hoffmann-La Roche
Information provided by:	Azienda Ospedaliera di Padova
ClinicalTrials.gov Identifier:	NCT00502632

Purpose

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	Intervention	Phase
Pleural Empyema	Drug: Urokinase and Dornase alfa Drug: Urokinase	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Multicentre Randomized Double-Blinded Trial of Intrapleural Dornase Alfa and Urokinase vs Urokinase Alone for Complicated Parapneumonic Effusions in Children

Resource links provided by NLM:

Drug Information available for: Dornase alfa Urokinase

U.S. FDA Resources

Further study details as provided by Azienda Ospedaliera di Padova:

Primary Outcome Measures:

Duration of hospital stay [ Time Frame: From beginning of intrapleural treatment ] [ Designated as safety issue: No ]
Need for additional surgical procedures [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of suction applied to chest drain [ Time Frame: From beginning of intrapleural treatment ] [ Designated as safety issue: No ]
Duration of fever [ Time Frame: From beginning of intrapleural treatment ] [ Designated as safety issue: No ]
Duration of intravenous antibiotic treatment [ Time Frame: From beginning of intrapleural treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	94
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2009

Arms	Assigned Interventions
1: Experimental 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
2: Placebo Comparator 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

Eligibility

Ages Eligible for Study:	1 Year to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502632

Contacts

Contact: PierGiorgio Gamba, MD

+39 049 821 3683

piergiorgio.gamba@unipd.it

Locations

Italy
Azienda Ospedaliera di Padova	Recruiting
Padova, Italy, 35128
Contact: PierGiorgio Gamba, MD +39 049 821 3683 piergiorgio.gamba@unipd.it
Sub-Investigator: Eleonora Cesca, MD
Sub-Investigator: Sonia Viale, MD
Ospedale Bambino Gesu'	Recruiting
Roma, Italy, 00165
Contact: Alessandro Inserra, MD +39 06 6859 2423 lobina@opbg.net
Principal Investigator: Alessandro Inserra, MD
Ospedali Riuniti di Bergamo	Recruiting
Bergamo, Italy, 24128
Contact: Maurizio Cheli, MD mauriziocheli@tin.it
Principal Investigator: Maurizio Cheli, MD

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

More Information

No publications provided

Responsible Party:	Azienda Ospedaliera di Padova ( Dr PierGiorgio Gamba )
Study ID Numbers:	1372P
Study First Received:	July 16, 2007
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00502632 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera di Padova:

Pleural empyema
Pleural effusion
Dornase alfa
Urokinase
Children

Additional relevant MeSH terms:

Pathologic Processes
Empyema, Pleural
Respiratory Tract Diseases
Respiratory Tract Infections
Pleural Diseases

Suppuration
Empyema
Infection
Inflammation

ClinicalTrials.gov processed this record on February 08, 2010