The second multi-centre intra-pleural sepsis trial (MIST2), to assess whether DNase or Alteplase, improve pleural fluid drainage in pleural infection
| ISRCTN | ISRCTN57454527 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57454527 |
| EudraCT/CTIS number | 2004-000658-22 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/05/2004
- Registration date
- 11/10/2004
- Last edited
- 15/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=46
Contact information
Dr Najib Rahman
Scientific
Scientific
Academic Clinical Lecturer
Oxford Respiratory Trials Unit
University of Oxford
Churchill Hospital
Old Road, Headington
Oxford
OX3 7LJ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Multi-centre Intra-pleural Sepsis Trial (MIST2) |
| Study objectives | 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. |
| Ethics approval(s) | Eastern Multi-Research Ethics Committee (latterly Cambridgeshire 4 REC) on 16/12/2004 (ref: 04/mre05/53) |
| Health condition(s) or problem(s) studied | Pleural infection |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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). |
| Secondary outcome measures | 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 |
| Overall study start date | 11/10/2003 |
| Completion date | 11/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | Added as of 10/09/2007: 210 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 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 |
| Date of first enrolment | 11/10/2003 |
| Date of final enrolment | 11/10/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Clinical Lecturer
Oxford
OX3 7LJ
United Kingdom
OX3 7LJ
United Kingdom
Sponsor information
Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
R&D Office
Manor House
The John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
England
United Kingdom
"ROR" |
https://ror.org/03h2bh287 |
|---|
Funders
Funder type
Industry
Unrestricted educational grant from Roche UK
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/08/2011 | Yes | No |
