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ISRCTN
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ISRCTN57454527
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ClinicalTrials.gov identifier
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Public title
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The second multi-centre intra-pleural sepsis trial (MIST2), to assess whether DNase or Alteplase, improve pleural fluid drainage in pleural infection
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Scientific title
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Acronym
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Multi-centre Intra-pleural Sepsis Trial (MIST2)
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Serial number at source
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N/A
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Study hypothesis
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Pleural infection - an infection of the area around the lungs - can occur when people have lung diseases such as pneumonia. Doctors often try to drain the fluid around the lungs to try to treat this. But sometimes this can be hard to do successfully. Some people have to have an operation, and some people may die as a result of the infection. Researchers think that the drugs DNase and Alteplase, which are already used to treat other illnesses, might help to treat pleural infection. The MIST2 trial aims to test whether these drugs are safe, and whether they can help to drain the fluid around the lungs. We are doing this trial in partnership with the Respiratory Trials Unit at the Churchill Hospital, Oxford.
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Lay summary
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http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=46
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Ethics approval
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Eastern Multi-Research Ethics Committee (latterly Cambridgeshire 4 REC) on 16/12/2004
(ref: 04/mre05/53)
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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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Pleural infection
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Participants - inclusion criteria
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1.A clinical presentation compatible with pleural infection
2. Has pleural fluid requiring drainage which is either purulent, gram stain positive, culture positive or acidic with a pH<7.2
3. Written informed consent
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Participants - exclusion criteria
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1. Age <18 years
2. Has previously received intra-pleural fibrinolytics or DNase for this empyema
3. Has a known sensitivity to DNase or tissue plasminogen activator
4. Has had a coincidental stroke, a major haemorrhage or major trauma
5. Has had major surgery in the previous 5 days
6. Has had a previous pneumonectomy on the side of infection
Patients who are pregnant or lactating (females of childbearing potential must have a negative pregnancy test before randomisation)
Expected survival less than three months from a different pathology to this empyema (e.g. metastatic lung carcinoma)
Inability to give informed consent
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Anticipated start date
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11/10/2003
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Anticipated end date
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11/10/2007
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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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Added as of 10/09/2007: 210
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Interventions
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Patients will be randomly assigned in the ratio 1:1:1:1 to either of the following regimes:
Alteplase 10 mg bd (twice a day) intrapleurally + DNase 5 mg bd intrapleurallly; or
Alteplase placebo intrapleurally + DNase 5 mg bd intrapleurally; or
Alteplase 10 mg bd intrapleurally + DNase placebo intrapleurally; or
Alteplase placebo intrapleurally + DNase placebo intrapleurally.
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Primary outcome measure(s)
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The primary endpoint will be radiographic improvement in area of pleural collection (between the area of the pleural collection on the CXR at randomisation and the chest radiograph taken on day 6/7).
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Secondary outcome measure(s)
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Secondary outcome measure(s):
1. Changes in blood CRP from baseline to day 6/7
2. Time from randomisation to remain apyrexial for 36 hrs
3. Total pleural fluid drainage
4. Survival and need for surgery at 3 and 12 months
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Sources of funding
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Unrestricted educational grant from Roche UK
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Trial website
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Publications
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1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21830966
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Contact name
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Dr
Najib
Rahman
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Address
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Academic Clinical Lecturer
Oxford Respiratory Trials Unit
University of Oxford
Churchill Hospital
Old Road, 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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Sponsor
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Oxford Radcliffe Hospitals NHS Trust (UK)
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Address
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R&D Office
Manor House
The John Radcliffe Hospital
Headley Way
Headington
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City/town
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Oxford
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Zip/Postcode
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OX3 9DU
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Country
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United Kingdom
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Date applied
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24/05/2004
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Last edited
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15/08/2011
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Date ISRCTN assigned
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11/10/2004
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