The British Thoracic Society trial to assess the safety and efficacy of intra-pleural streptokinase in pleural infection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN39138989

Enrollment

500

Registered

2000-10-25

Start date

1999-01-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Respiratory disease Respiratory Pleural effusion

Interventions

500 Hospital inpatients randomised 1 to 1 to intra-pleural streptokinase or placebo

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026