PneumoniaGAinSNCT00131196
Functional Genomic Influences on Disease Progression and Outcome in Sepsis
An observational study of Pneumonia and Peritonitis, run by University of Oxford at 50 sites in United Kingdom.
Trial summary
The proposal is aimed at identifying genetic factors that determine the incidence and severity of, and the outcome from life-threatening infections (severe sepsis/septic shock) in patients admitted to High Dependency Units (HDUs) or Intensive Care Units (ICUs) with pneumonia which developed outside the hospital… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Peritonitis
- How many people
- 4,000 participants
- Where
- 50 sitesUnited Kingdom
- Study dates
- Sep 2005to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Intensive Care Units or High Dependency Units in the UK with faecal peritonitis or community acquired pneumonia
Who may be able to join
- Patient, or legal representative, is able to give informed consent
- Male or female of 18 years or more
- Patient admitted to ICU/HDU with faecal peritonitis or community acquired pneumonia
Who cannot join
- Patient or legal representative is unwilling to consent
- Patient is under the age of 18 years
- Patient is already enrolled in an interventional study
- Patient is immunocompromised
- Patient is pregnant
- There is an advance directive to withhold or withdraw life-sustaining treatment or patient is admitted for palliative care only.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United Kingdom50 sites, 7 recruiting
- Completed
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
- Completed
Antrim Hospital
Antrim, County Antrim, BT41 2RL
- Recruiting
Queen Elizabeth Hospital
Birmingham, West Midlands, B15 2TH
Julian Bion, MD, 0121 627 1627, j.f.bion@bham.ac.uk
Julian Bion, MD
- Completed
Royal Blackburn Hospital
Blackburn, Lancashire, BB2 3HH
- Completed
Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR
- Completed
Royal Sussex County Hospital
Brighton, Sussex, BN2 5BE
- Completed
Southmead Hospital
Bristol, Avon, BS10 5NB
- Completed
Bristol Royal Infirmary
Bristol, Gloucestershire, BS2 8HW
- Completed
Frenchay Hospital
Bristol, South Gloucestershire, BS16 1LE
- Completed
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 2QQ
- Completed
University Hospital of Wales
Cardiff, South Glamorgan, CF14 4XW
- Completed
Broomfield Hospital
Chelmsford, Essex, CM1 7ET
- Completed
Cheltenham General Hospital
Cheltenham, Gloucestershire, GL53 7AN
- Completed
Colchester General Hospital
Colchester, Essex, CO4 5JL
- Completed
Castle Hill Hospital
Cottingham, East Riding of Yorkshire, HU16 5JQ
- Completed
University Hospital
Coventry, Warwickshire, CV2 2DX
- Completed
Frimley Park Hospital
Frimley, Surrey, GU16 7UJ
- Completed
Calderdale Royal Hospital
Halifax, West Yorkshire, HX3 0PW
- Completed
Huddersfield Royal Infirmary
Huddersfield, West Yorkshire, HD3 3EA
- Completed
Hull Royal Infirmary
Hull, Yorkshire, HU3 2JZ
- Completed
The Ipswich Hospital
Ipswich, Suffolk, IP4 5PD
- Completed
Kettering General Hospital
Kettering, Northants, NN16 8UZ
- Completed
Queen Elizabeth Hospital
Kings Lynn, Norfolk, PE30 4ET
- Completed
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF
- Recruiting
Leicester Royal Infirmary
Leicester, Leicestershire, LE1 5WW
Jonathan Thompson, MD, 0300 303 1573, jonathan.thompson@uhl-tr.nhs.uk
Jonathan Thompson, MD
- Recruiting
Glenfield Hospital
Leicester, LE3 9QP
Jonathan Thompson, MD, 0300 303 1573, jonathan.thompson@uhl-tr.nhs.uk
Jonathan Thompson, MD
- Recruiting
Leicester General Hospital
Leicester, LE5 4PW
Jonathon Thompson, MD, jonathan.thompson@uhl-tr.nhs.uk
Jonathon Thompson, MD
- Completed
University Hospital Lewisham
Lewisham, London, SE13 6LH
- Completed
Homerton Hospital
London, E9 6SR
- Recruiting
St Bartholomew's Hospital
London, EC1A 7BE
Charles Hinds, MD, 020 7377 7000, C.J.Hinds@qmul.ac.uk
Charles Hinds, MD
- Completed
North Middlesex University Hospital
London, N18 1QX
- Completed
Chelsea and Westminster Hospital
London, SW10 9NH
- Completed
Hammersmith Hospital
London, W12 0HS
- Completed
UCLH Middlesex Hospital
London, W1T 3AA
- Completed
St Mary's Hospital
London, W2 1NY
- Completed
Charing Cross Hospital
London, W6 8RF
- Completed
Withington Hospital
Manchester, Greater Manchester, M20 2LR
- Completed
Wythenshawe Hospital
Manchester, Greater Manchester, M23 9LT
- Completed
Hope Hospital
Manchester, Greater Manchester, M6 8HD
- Completed
James Cook University Hospital
Middlesbrough, Cleveland, TS4 3BW
- Completed
Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
- Completed
Norfolk and Norwich University Hospitals
Norwich, Norfolk, NR4 7UZ
- Recruiting
John Radcliffe Hospital
Oxford, Oxon, OX3 9DU
Christopher Garrard, MD, 01865 220621, chris.garrard@ndm.ox.ac.uk
Christopher Garrard, MD
- Completed
Royal Preston Hospital
Preston, Lancashire, PR2 9HT
- Recruiting
Royal Berkshire Hospital
Reading, Berkshire, RG1 5AN
Atul Kapila, MD, 0118 9875111, Atul.Kapila@rbbh-tr.nhs.uk
Atul Kapila, MD
- Completed
Royal Halamshire Hospital
Sheffield, S10 2JF
- Completed
Southend General Hospital
Southend, Essex, SS0 0RY
- Completed
The Great Western Hospital
Swindon, SN3 6BB
- Completed
Walsall Manor Hospital
Walsall, West Midlands, WS2 9PS
- Completed
Worthing and Southlands Hospitals NHS Trust
Worthing, West Sussex, BN11 2DH
About this study
Official title: Functional Genomic Influences on Disease Progression and Outcome in Sepsis Due to Pneumonia or Peritonitis
The proposal is aimed at identifying genetic factors that determine the incidence and severity of, and the outcome from life-threatening infections (severe sepsis/septic shock) in patients admitted to High Dependency Units (HDUs) or Intensive Care Units (ICUs) with pneumonia which developed outside the hospital (community acquired pneumonia - CAP) or contamination of the abdominal cavity with faeces due to a leak in the bowel (faecal peritonitis). This will require the acquisition of a large, high quality resource of genetic material (DNA), plasma, urine, white blood cells and clinical information from well characterized groups of similar patients with, or at risk for, severe sepsis/septic shock. The principal objective is to perform studies which are sufficiently large to establish beyond doubt the influence of a series of selected "candidate" genes on the development, progress and outcome of sepsis.
Read the detailed description
The investigators plan to recruit 2,000 cases of community acquired pneumonia (CAP) and 2,000 cases of faecal peritonitis (FP) from 30 UK ICUs and HDUs (members of the UK Critical Care Genomics group - UKCCG). The large number of patients is required to satisfy the power calculations based upon the predicted allele frequencies of candidate genes and the level of functional expression of the gene polymorphisms.
If a patient is eligible, written, informed consent will be obtained either from the patient or, if the patient is incompetent via the patient's legal representative. Patients will be characterized clinically in terms of admission diagnosis, severity of illness (APACHE II), organ failures (SOFA) and final outcome (ICU and hospital mortality, death or survival 6 months following ICU admission. Date of death will be recorded when appropriate). Clinical status will be assessed daily for days 1, 2, 3, 5 and 7 of ICU admission using the Sepsis criteria, SOFA score, microbiological culture results and antibiotic therapy.
Selected ICUs will, following consent, also undertake blood and urine sampling on days 1, 3 and 5 for genomic, proteomic and metabolomic studies. Information will be recorded on a bar-coded paper clinical report form (CRF) at the bedside. The CRFs will be securely stored locally and copied to the research coordinator, where they will be archived. The data will be entered independently by the research coordinator and one of the investigators into a secure, central web-based electronic database for storage of clinical data and the calculation of derived values. The patient codes for genetic analysis will be derived directly from the clinical database. Those undertaking genotyping will be blinded to the clinical details and these two databases will be brought together at the time of analysis only under the direct supervision of one of the principal investigators.
- Conditions
- Pneumonia, Peritonitis
- Keywords
- pneumonia, peritonitis, sepsis, outcome, genomics
- Medical subject headings
- Pneumonia, Peritonitis, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU and hospital Mortality
Measured: ICU discharge, hospital discharge and 6 month. The date of death will be recorded, as appropriate, for each patient.
Secondary outcomes (1)
Severity of illness, duration of organ support, shock reversal, duration of ICU and hospital stay
Measured: From ICU admission to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Sainsbury Family Charitable Trusts, Wellcome Trust, Queen Mary University of London, Barts and the London School of Medicine and Dentistry
- Responsible party
- Principal investigator, Dr CS Garrard, University of Oxford
- Investigators
- Christopher S Garrard, MD PhD, Principal investigator, University of Oxford, UKCharles J Hinds, MD, Principal investigator, Queen Mary College, University of London, UKSimon Baudouin, MD, Principal investigator, Royal Victoria Infirmary and Freeman Hospital, Newcastle, UKDavid Higgins, MD, Principal investigator, Southend General Hospital, Southend, UK.Richard Venn, MD, Principal investigator, Worthing and Southlands Hospitals NHS Trust, Worthing, UK.David Watson, MD, Principal investigator, Homerton University Hospital, London, UK.Atul Kapila, MD, Principal investigator, Royal Berkshire Hospital, Reading, UK.Simon Fletcher, MD, Principal investigator, Norfolk and Norwich University Hospitals, Norwich, UK.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131196
- Sponsor's protocol ID
- N8518
- Acronym
- GAinS
- Status last verified
- May 2016
- First submitted
- 15 Aug 2005
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vincent JL, Angus D, Annane D, Bernard G, Faist E, Giroir B, Reinhart K. Clinical expert round table discussion (session 5) at the Margaux Conference on Critical Illness: outcomes of clinical trials in sepsis: lessons learned. Crit Care Med. 2001 Jul;29(7 Suppl):S136-7. doi: 10.1097/00003246-200107001-00040. No abstract available.
PubMed 11445749Brun-Buisson C, Doyon F, Carlet J, Dellamonica P, Gouin F, Lepoutre A, Mercier JC, Offenstadt G, Regnier B. Incidence, risk factors, and outcome of severe sepsis and septic shock in adults. A multicenter prospective study in intensive care units. French ICU Group for Severe Sepsis. JAMA. 1995 Sep 27;274(12):968-74.
PubMed 7674528File TM. Community-acquired pneumonia. Lancet. 2003 Dec 13;362(9400):1991-2001. doi: 10.1016/S0140-6736(03)15021-0.
PubMed 14683661Gordon AC, Lagan AL, Aganna E, Cheung L, Peters CJ, McDermott MF, Millo JL, Welsh KI, Holloway P, Hitman GA, Piper RD, Garrard CS, Hinds CJ. TNF and TNFR polymorphisms in severe sepsis and septic shock: a prospective multicentre study. Genes Immun. 2004 Dec;5(8):631-40. doi: 10.1038/sj.gene.6364136.
PubMed 15526005Mira JP, Cariou A, Grall F, Delclaux C, Losser MR, Heshmati F, Cheval C, Monchi M, Teboul JL, Riche F, Leleu G, Arbibe L, Mignon A, Delpech M, Dhainaut JF. Association of TNF2, a TNF-alpha promoter polymorphism, with septic shock susceptibility and mortality: a multicenter study. JAMA. 1999 Aug 11;282(6):561-8. doi: 10.1001/jama.282.6.561.
PubMed 10450718Sands KE, Bates DW, Lanken PN, Graman PS, Hibberd PL, Kahn KL, Parsonnet J, Panzer R, Orav EJ, Snydman DR, Black E, Schwartz JS, Moore R, Johnson BL Jr, Platt R; Academic Medical Center Consortium Sepsis Project Working Group. Epidemiology of sepsis syndrome in 8 academic medical centers. JAMA. 1997 Jul 16;278(3):234-40.
PubMed 9218672Sorensen TI, Nielsen GG, Andersen PK, Teasdale TW. Genetic and environmental influences on premature death in adult adoptees. N Engl J Med. 1988 Mar 24;318(12):727-32. doi: 10.1056/NEJM198803243181202.
PubMed 3347221Roy S, Knox K, Segal S, Griffiths D, Moore CE, Welsh KI, Smarason A, Day NP, McPheat WL, Crook DW, Hill AV; Oxford Pneumoccocal Surveillance Group. MBL genotype and risk of invasive pneumococcal disease: a case-control study. Lancet. 2002 May 4;359(9317):1569-73. doi: 10.1016/S0140-6736(02)08516-1.
PubMed 12047967Scicluna BP, Cano-Gamez K, Burnham KL, Davenport EE, Moore AR, Khan S, Hinds CJ, Cremer OL, Khatri P, Sweeney TE, Knight JC, van der Poll T. A consensus blood transcriptomic framework for sepsis. Nat Med. 2025 Dec;31(12):4119-4130. doi: 10.1038/s41591-025-03964-5. Epub 2025 Sep 30.
PubMed 41028542
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Genomic Influences on Disease Progression and Outcome in Sepsis Due to Pneumonia or Peritonitis
- ClinicalTrials.gov ID
- NCT00131196
- Acronym / sponsor ID
- GAinS / N8518
- Conditions
- Pneumonia, Peritonitis
- Keywords
- pneumonia, peritonitis, sepsis, outcome, genomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Sainsbury Family Charitable Trusts, Wellcome Trust, Queen Mary University of London, Barts and the London School of Medicine and Dentistry
- Study start
- Sep 2005
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposal is aimed at identifying genetic factors that determine the incidence and severity of, and the outcome from life-threatening infections (severe sepsis/septic shock) in patients admitted to High Dependency Units (HDUs) or Intensive Care Units (ICUs) with pneumonia which developed outside the hospital (community acquired pneumonia - CAP) or contamination of the abdominal cavity with faeces due to a leak in the bowel (faecal peritonitis). This will require the acquisition of a large, high quality resource of genetic material (DNA), plasma, urine, white blood cells and clinical information from well characterized groups of similar patients with, or at risk for, severe sepsis/septic shock. The principal objective is to perform studies which are sufficiently large to establish beyond doubt the influence of a series of selected "candidate" genes on the development, progress and outcome of sepsis.
Detailed description
The investigators plan to recruit 2,000 cases of community acquired pneumonia (CAP) and 2,000 cases of faecal peritonitis (FP) from 30 UK ICUs and HDUs (members of the UK Critical Care Genomics group - UKCCG). The large number of patients is required to satisfy the power calculations based upon the predicted allele frequencies of candidate genes and the level of functional expression of the gene polymorphisms.
If a patient is eligible, written, informed consent will be obtained either from the patient or, if the patient is incompetent via the patient's legal representative. Patients will be characterized clinically in terms of admission diagnosis, severity of illness (APACHE II), organ failures (SOFA) and final outcome (ICU and hospital mortality, death or survival 6 months following ICU admission. Date of death will be recorded when appropriate). Clinical status will be assessed daily for days 1, 2, 3, 5 and 7 of ICU admission using the Sepsis criteria, SOFA score, microbiological culture results and antibiotic therapy.
Selected ICUs will, following consent, also undertake blood and urine sampling on days 1, 3 and 5 for genomic, proteomic and metabolomic studies. Information will be recorded on a bar-coded paper clinical report form (CRF) at the bedside. The CRFs will be securely stored locally and copied to the research coordinator, where they will be archived. The data will be entered independently by the research coordinator and one of the investigators into a secure, central web-based electronic database for storage of clinical data and the calculation of derived values. The patient codes for genetic analysis will be derived directly from the clinical database. Those undertaking genotyping will be blinded to the clinical details and these two databases will be brought together at the time of analysis only under the direct supervision of one of the principal investigators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Intensive Care Units or High Dependency Units in the UK with faecal peritonitis or community acquired pneumonia
Key inclusion criteria (3 listed)
- Patient, or legal representative, is able to give informed consent
- Male or female of 18 years or more
- Patient admitted to ICU/HDU with faecal peritonitis or community acquired pneumonia
Key exclusion criteria (6 listed)
- Patient or legal representative is unwilling to consent
- Patient is under the age of 18 years
- Patient is already enrolled in an interventional study
- Patient is immunocompromised
- Patient is pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU and hospital Mortality
Time frame: ICU discharge, hospital discharge and 6 month. The date of death will be recorded, as appropriate, for each patient.
1 secondary outcome
Severity of illness, duration of organ support, shock reversal, duration of ICU and hospital stay
Time frame: From ICU admission to discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Background: PubMed 11445749Vincent JL, Angus D, Annane D, Bernard G, Faist E, Giroir B, Reinhart K. Clinical expert round table discussion (session 5) at the Margaux Conference on Critical Illness: outcomes of clinical trials in sepsis: lessons learned. Crit Care Med. 2001 Jul;29(7 Suppl):S136-7. doi: 10.1097/00003246-200107001-00040. No abstract available.
- Background: PubMed 7674528Brun-Buisson C, Doyon F, Carlet J, Dellamonica P, Gouin F, Lepoutre A, Mercier JC, Offenstadt G, Regnier B. Incidence, risk factors, and outcome of severe sepsis and septic shock in adults. A multicenter prospective study in intensive care units. French ICU Group for Severe Sepsis. JAMA. 1995 Sep 27;274(12):968-74.
- Background: PubMed 14683661File TM. Community-acquired pneumonia. Lancet. 2003 Dec 13;362(9400):1991-2001. doi: 10.1016/S0140-6736(03)15021-0.
- Background: PubMed 15526005Gordon AC, Lagan AL, Aganna E, Cheung L, Peters CJ, McDermott MF, Millo JL, Welsh KI, Holloway P, Hitman GA, Piper RD, Garrard CS, Hinds CJ. TNF and TNFR polymorphisms in severe sepsis and septic shock: a prospective multicentre study. Genes Immun. 2004 Dec;5(8):631-40. doi: 10.1038/sj.gene.6364136.
- Background: PubMed 10450718Mira JP, Cariou A, Grall F, Delclaux C, Losser MR, Heshmati F, Cheval C, Monchi M, Teboul JL, Riche F, Leleu G, Arbibe L, Mignon A, Delpech M, Dhainaut JF. Association of TNF2, a TNF-alpha promoter polymorphism, with septic shock susceptibility and mortality: a multicenter study. JAMA. 1999 Aug 11;282(6):561-8. doi: 10.1001/jama.282.6.561.
- Background: PubMed 9218672Sands KE, Bates DW, Lanken PN, Graman PS, Hibberd PL, Kahn KL, Parsonnet J, Panzer R, Orav EJ, Snydman DR, Black E, Schwartz JS, Moore R, Johnson BL Jr, Platt R; Academic Medical Center Consortium Sepsis Project Working Group. Epidemiology of sepsis syndrome in 8 academic medical centers. JAMA. 1997 Jul 16;278(3):234-40.
- Background: PubMed 3347221Sorensen TI, Nielsen GG, Andersen PK, Teasdale TW. Genetic and environmental influences on premature death in adult adoptees. N Engl J Med. 1988 Mar 24;318(12):727-32. doi: 10.1056/NEJM198803243181202.
- Background: PubMed 12047967Roy S, Knox K, Segal S, Griffiths D, Moore CE, Welsh KI, Smarason A, Day NP, McPheat WL, Crook DW, Hill AV; Oxford Pneumoccocal Surveillance Group. MBL genotype and risk of invasive pneumococcal disease: a case-control study. Lancet. 2002 May 4;359(9317):1569-73. doi: 10.1016/S0140-6736(02)08516-1.
- Derived from this study: PubMed 41028542Scicluna BP, Cano-Gamez K, Burnham KL, Davenport EE, Moore AR, Khan S, Hinds CJ, Cremer OL, Khatri P, Sweeney TE, Knight JC, van der Poll T. A consensus blood transcriptomic framework for sepsis. Nat Med. 2025 Dec;31(12):4119-4130. doi: 10.1038/s41591-025-03964-5. Epub 2025 Sep 30.
- GAinS Website (Genomic Advances in Sepsis)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher S Garrard, MD PhD principal investigator
University of Oxford, UK
Charles J Hinds, MD principal investigator
Queen Mary College, University of London, UK
Simon Baudouin, MD principal investigator
Royal Victoria Infirmary and Freeman Hospital, Newcastle, UK
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Peritonitis, run by University of Oxford at 50 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charles J Hinds, MD (+44 20346 57294, c.j.hinds@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU and hospital Mortality (time frame: ICU discharge, hospital discharge and 6 month. The date of death will be recorded, as appropriate, for each patient.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00131196, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.