The British Thoracic Society trial to assess the safety and efficacy of intra-pleural streptokinase in pleural infectio
Completed
- Conditions
- Respiratory diseaseRespiratoryPleural effusion
- Registration Number
- ISRCTN39138989
- Lead Sponsor
- Medical Research Council (MRC) (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
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
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoints<br>a. Therapeutic failure requiring thoracic surgery or death<br>1. At 3 months and<br>2. At 1 year post-randomisation <br>b. Serious or severe adverse events <br>The definition of therapeutic failure requiring thoracic surgery will be left to the discretion of the managing physician<br> <br>Secondary endpoints<br>a. Duration of hospital stay <br>b. Residual chest radiograph abnormality at three months post-randomisation<br>c. Lung function at three months post-randomisation
- Secondary Outcome Measures
Name Time Method ot provided at time of registration