Dornase Alfa and Urokinase for Kids With Pleural Empyema

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00502632

Acronym

DUKE

Enrollment

Registered

2007-07-17

Start date

2007-10-31

Completion date

2009-10-31

Last updated

2008-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pleural Empyema

Keywords

Pleural empyema, Pleural effusion, Dornase alfa, Urokinase, Children

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

Interventions

DRUGUrokinase 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

DRUGUrokinase

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 16 Years

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

Design outcomes

Primary

Measure	Time frame
Duration of hospital stay	From beginning of intrapleural treatment
Need for additional surgical procedures	3 months

Secondary

Measure	Time frame
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

Countries

Italy

Contacts

Primary ContactPierGiorgio Gamba, MD

piergiorgio.gamba@unipd.it+39 049 821 3683

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026