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Dornase Alfa and Urokinase for Kids With Pleural Empyema

NCT ID: NCT00502632

Last Updated: 2008-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Pleural Empyema

Keywords

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Pleural empyema Pleural effusion Dornase alfa Urokinase Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Urokinase and Dornase alfa

Intervention Type DRUG

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

Intrapleural administration of:

* Urokinase 40,000 in 40ml normal saline, twice daily for 4 days
* 25ml normal saline, twice daily for 4 days

Group Type PLACEBO_COMPARATOR

Urokinase

Intervention Type DRUG

Intrapleural administration of:

* Urokinase 40,000 in 40ml normal saline, twice daily for 4 days
* 25ml normal saline, twice daily for 4 days

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Azienda Ospedaliera di Padova

OTHER

Sponsor Role lead

Responsible Party

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Azienda Ospedaliera di Padova

Principal Investigators

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PierGiorgio Gamba, MD

Role: STUDY_CHAIR

Azienda Ospedaliera di Padova

Giorgio Stefanutti, MD

Role: PRINCIPAL_INVESTIGATOR

Women's and Children's Hospital, Adelaide, SA

Locations

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Ospedali Riuniti di Bergamo

Bergamo, , Italy

Site Status RECRUITING

Azienda Ospedaliera di Padova

Padua, , Italy

Site Status RECRUITING

Ospedale Bambino Gesu'

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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PierGiorgio Gamba, MD

Role: CONTACT

Phone: +39 049 821 3683

Email: [email protected]

Facility Contacts

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Maurizio Cheli, MD

Role: primary

PierGiorgio Gamba, MD

Role: primary

Alessandro Inserra, MD

Role: primary

Other Identifiers

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1372P

Identifier Type: -

Identifier Source: org_study_id