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

ISRCTN	ISRCTN39138989
DOI	https://doi.org/10.1186/ISRCTN39138989
Protocol serial number	G9721289
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Robert JO Davies
Scientific

Respiratory Trials Unit
Osler Chest Unit
The Churchill Hospital
Headington
Oxford
OX3 7LJ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To evaluate the efficacy and safety of intrapleural streptokinase given to patients with complicated parapneumonic effusions and empyema to improve pleural drainage
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Respiratory disease
Intervention	500 Hospital inpatients randomised 1 to 1 to intra-pleural streptokinase or placebo
Intervention type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	07/08/2003

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	500
Key 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
Key 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
Date of first enrolment	01/01/1999
Date of final enrolment	07/08/2003

Respiratory Trials Unit

Oxford
OX3 7LJ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/03/2005		Yes	No