NCT00502632

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

May 12, 2008

Status Verified

May 1, 2008

First QC Date

July 16, 2007

Last Update Submit

May 9, 2008

Conditions

Pleural Empyema

Keywords

Pleural empyemaPleural effusionDornase alfaUrokinaseChildren

Outcome Measures

Primary Outcomes (2)

  • Duration of hospital stay

    From beginning of intrapleural treatment

  • Need for additional surgical procedures

    3 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

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

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

Interventions

Urokinase and Dornase alfaDRUG

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

1
UrokinaseDRUG

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

2

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ospedali Riuniti di Bergamo

Bergamo, 24128, Italy

RECRUITING

Azienda Ospedaliera di Padova

Padua, 35128, Italy

RECRUITING

Ospedale Bambino Gesu'

Roma, 00165, Italy

RECRUITING

MeSH Terms

Conditions

Empyema, PleuralPleural Effusion

Interventions

Urokinase-Type Plasminogen Activatordornase alfa

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsEmpyemaSuppurationPleural DiseasesRespiratory Tract DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • PierGiorgio Gamba, MD

    Azienda Ospedaliera di Padova

    STUDY CHAIR

  • Giorgio Stefanutti, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

PierGiorgio Gamba, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 17, 2007

Study Start

October 1, 2007

Study Completion

October 1, 2009

Last Updated

May 12, 2008

Record last verified: 2008-05

Locations

IT(3)