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ISRCTN
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ISRCTN39138989
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DOI
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10.1186/ISRCTN39138989
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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The British Thoracic Society trial to assess the safety and efficacy of intra-pleural streptokinase in pleural infection
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Scientific title
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Acronym
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N/A
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Serial number at source
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G9721289
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Study hypothesis
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To evaluate the efficacy and safety of intrapleural streptokinase given to patients with complicated parapneumonic effusions and empyema to improve pleural drainage
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Respiratory disease
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Participants - inclusion criteria
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1. Purulent or positive Gram stain or positive culture pleural fluid
2. Acidic pleural effusion (pH less than 7.2) in the presence of clinical pneumonia
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Participants - exclusion criteria
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1. Age less than 18 years
2. A serious illness making survival at three months unlikely.
3. Previous intrapleural fibrinolytics for this empyema
4. Previous video assisted thoracoscopic drainage, thoracotomy, pleural decortification or open drainage for this empyema
5. Known sensitivity to streptokinase.
6. Coincidental stroke or major haemorrhage
7. Major surgery within previous 5 days
8. Previous pneumonectomy on same side of infection.
9. Pleural malignancy
10. females who are pregnant or lactating
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Anticipated start date
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01/01/1999
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Anticipated end date
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07/08/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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500
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Interventions
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500 Hospital inpatients randomised 1 to 1 to intra-pleural streptokinase or placebo
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Primary outcome measure(s)
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Primary Endpoints
a. Therapeutic failure requiring thoracic surgery or death
1. At 3 months and
2. At 1 year post-randomisation
b. Serious or severe adverse events
The definition of therapeutic failure requiring thoracic surgery will be left to the discretion of the managing physician
Secondary endpoints
a. Duration of hospital stay
b. Residual chest radiograph abnormality at three months post-randomisation
c. Lung function at three months post-randomisation
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15745977
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Contact name
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Dr
Robert JO
Davies
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Address
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Respiratory Trials Unit
Osler Chest Unit
The Churchill Hospital
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 7LJ
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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07/09/2009
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Date ISRCTN assigned
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25/10/2000
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