Dornase Alfa and Urokinase for Kids With Pleural Empyema

Condition(s) targeted: Pleural Empyema

Intervention: Urokinase and Dornase alfa (Drug); Urokinase (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: Azienda Ospedaliera di Padova

Official(s) and/or principal investigator(s):
PierGiorgio Gamba, MD, Study Chair, Affiliation: Azienda Ospedaliera di Padova
Giorgio Stefanutti, MD, Principal Investigator, Affiliation: Women's and Children's Hospital, Adelaide, SA

Overall contact:
PierGiorgio Gamba, MD, Phone: +39 049 821 3683, Email: piergiorgio.gamba@unipd.it

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

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Duration of hospital stay

Need for additional surgical procedures

Secondary outcome:

Duration of suction applied to chest drain

Duration of fever

Duration of intravenous antibiotic treatment

Minimum age: 1 Year. Maximum age: 16 Years. Gender(s): Both.

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

PierGiorgio Gamba, MD, Phone: +39 049 821 3683, Email: piergiorgio.gamba@unipd.it

Ospedali Riuniti di Bergamo, Bergamo 24128, Italy; Recruiting
Maurizio Cheli, MD, Email: mauriziocheli@tin.it
Maurizio Cheli, MD, Principal Investigator

Azienda Ospedaliera di Padova, Padova 35128, Italy; Recruiting
PierGiorgio Gamba, MD, Phone: +39 049 821 3683, Email: piergiorgio.gamba@unipd.it
Eleonora Cesca, MD, Sub-Investigator
Sonia Viale, MD, Sub-Investigator

Ospedale Bambino Gesu', Roma 00165, Italy; Recruiting
Alessandro Inserra, MD, Phone: +39 06 6859 2423, Email: lobina@opbg.net
Alessandro Inserra, MD, Principal Investigator

Starting date: October 2007
Last updated: May 9, 2008