Condition category
Respiratory
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
07/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert JO Davies

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9721289

Study information

Scientific title

Acronym

Study hypothesis

To evaluate the efficacy and safety of intrapleural streptokinase given to patients with complicated parapneumonic effusions and empyema to improve pleural drainage

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Respiratory disease

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 outcome measures

Not provided at time of registration

Overall trial start date

01/01/1999

Overall trial end date

07/08/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

Participant 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

Recruitment start date

01/01/1999

Recruitment end date

07/08/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Respiratory Trials Unit
Oxford
OX3 7LJ
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15745977

Publication citations

  1. Results

    Maskell NA, Davies CW, Nunn AJ, Hedley EL, Gleeson FV, Miller R, Gabe R, Rees GL, Peto TE, Woodhead MA, Lane DJ, Darbyshire JH, Davies RJ, , U.K. Controlled trial of intrapleural streptokinase for pleural infection., N. Engl. J. Med., 2005, 352, 9, 865-874, doi: 10.1056/NEJMoa042473.

Additional files

Editorial Notes