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
Clinical Trials Information System (CTIS)	2004-000658-22
Protocol serial number	N/A
Sponsor	Oxford Radcliffe Hospitals NHS Trust (UK)
Funder	Unrestricted educational grant from Roche UK

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

Academic Clinical Lecturer
Oxford Respiratory Trials Unit
University of Oxford
Churchill Hospital
Old Road, Headington
Oxford
OX3 7LJ
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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).
Key secondary outcome measure(s)	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
Completion date	11/10/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Academic Clinical Lecturer

Oxford
OX3 7LJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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