Point of care testing for sepsis | Recruiting
Point of care testing for sepsis | Recruiting
Point of care testing for sepsis
TEST-IT

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Medical Conditions
  • Sepsis
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN97997760
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
Background and study aims
Sepsis is the term used to describe serious infections. Up to half of all hospitalised patients with sepsis may die. It is caused by microrganisms (microbes), such as bacteria, and one of the most important parts of treating patients with sepsis is to give them the right antibiotics as soon as possible to treat the underlying infection. Many different microbes can cause sepsis. Currently the only way to find out for sure which one to target in any particular patient is to wait for it to grow in a laboratory from a sample of their blood, or other samples (culture). As it takes at least 24-48 hours to grow in the laboratory, doctors choose 'best guess' antibiotics that can treat a lot of different microbes before they know which one would be the best fit. These are not always the right antibiotics for that particular individual, and sometimes patients only get the right treatment once there is a result from the laboratory. Randox Ltd has recently developed a new bedside device based on technology that is able to identify bacteria in patients' blood within just one hour. Looking only for characteristic fragments of over 40 different microbes means that doctors’ decisions about which treatment to give patients will not need to wait for over a day for the microbe to grow in a laboratory. This will allow treatments to be better targeted from a much earlier stage. The aim of this study is to investigate how well the new test is able to identify microbes in comparison to blood culture, which is currently the best method of measurement (gold standard).

Who can participate?
Patients aged 16 years who are admitted to ICU and are suspected of having sepsis.

What does the study involve?
Patients are screened daily by members of the clinical team and where a patient suspected of having sepsis requires a blood sample taken as part of routine clinical care; additional blood will be taken at this time and stored. At the time that the standard care blood culture is taken from a potential participant, a 5ml research sample of blood is also be collected for analysis with the new test.
An additional 10ml sample of blood is also collected on the first sampling occasion for a given patient when research staff are available at that time to process and store the sample. Each patient can contribute more than one sample to this study but there must be five days between each sample being taken.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved to the patients taking part in this study.

Where is the study run from?
At least 18 intensive care units in NHS hospitals in Northern Ireland and England (UK)

When is the study starting and how long is it expected to run for?
May 2015 to February 2018

Who is funding the study?
Innovate UK (UK)

Who is the main contact?
1. Dr Ronan McMullan (scientific)
ronan.mcmullan@belfasttrust.hscni.net
2. Mr Paul Doherty (public)
paul.doherty@nictu.hscni.net
Research Details
  • The Randox POC Multiplex PCR test has high diagnostic accuracy, in comparison with conventional culture, for detecting pathogens in critically ill adults with suspected sepsis.
Phase
Sorry, this information is not available
Study Design
Prospective observational multi-centre cross sectional diagnostic accuracy study
Study Type
Observational
Intervention

Adult patients admitted to ICU who undergo blood culture testing for suspected sepsis are eligible for this study and will be screened daily, on the basis of the inclusion/exclusion criteria as specified in the protocol. Blood cultures will be taken in the usual manner in the course of routine care. At the time that each blood culture is taken from an eligible patient, a 5ml sample of blood will also be collected for multiplex PCR testing. An additional 10ml sample of blood will also be collected where it is the first sample or research staff are available to process and store the sample. Each patient can contribute more than one sample to this study; however an interval of at least 5-days must lapse between consecutive samples obtained.

Reference standard: Automated blood culture technology, in place as standard NHS care in microbiology laboratories at participating sites, and performed prospectively as part of usual clinical care.

Index test: Microarray-based multiplex PCR for detection of DNA from a range of at least 40 sepsis pathogens. It will be carried out using an instrument which has been developed by Randox Ltd specifically for this test. The index test will be performed retrospectively in a centralised laboratory for the first part of the study and prospectively at study sites in the latter part of the study.

Intervention Type
Other
Primary Outcome Measures
    Diagnostic accuracy of the multiplex PCR test, expressed as sensitivity, specificity, and positive and negative predictive values, with uncertainty expressed using 95% confidence limits.
Secondary Outcome Measures
    1. Resource use associated with the multiplex PCR testing and conventional blood culture is measured by study-specific data collection forms at randomly generated time points over the course of the trial
    2. The time required to complete testing will be measured for both Multiplex PCR and the paired blood culture. In the case of the blood culture two measures will be recorded at:
    2.1. The time between sampling and the test first being reported to clinical teams as positive
    2.2. The time between sampling and a final pathogen identification first being reported to clinical teams. It is acknowledged that, for both of these, the result will usually be ‘first’ reported verbally
    Blood cultures that do not flag positive after 5-days of incubation will be categorised as negative with a time to result of 5-days.

    Exploratory outcome measures:
    1. Neutrophil activation biomarkers are measured by plasma MPO and MMP-8 in sample taken at time of reference standard
    2. Plasma and serum inflammatory response biomarkers are measured by CRP, cytokines (including but not limited to TNFα, IL-1β, IL-6, IL-8), proteases and anti-proteases, activation molecule expression (including but not limited to sICAM-1), coagulation factors (including but not limited to thrombin-anti-thrombin complex, tissue factor, protein C, thrombomodulin and plasminogen activator inhibitor-1), RAGE ligands and vitamin D status
    3. Pulmonary and systemic epithelial and endothelial function and injury are assessed through measuring plasma and serum biomarkers (including RAGE, Ang I/II, SP-D, vWF and PCP3) and urinary albumin/creatinine ratio in sample taken at time of reference standard
    4. Surrogate markers of inflammation are measured through primary cultures fresh human neutrophils monocytes and macrophages as well as mesenchymal stromal cells in sample taken at time of reference standard
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
4501 samples
Participant Inclusion Criteria
    1. Aged 16 years and over
    2. Patients with suspected sepsis
    3. Undergoing blood sampling for culture in the course of routine care
Participant Exclusion Criteria
    1. Patients aged <16 years old
    2. Patients previously recruited to the study
    3. Consent declined
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
GSK Investigational Site
Bordesley Green
B9 5SS
GSK Investigational Site
London
E1 1BB
GSK Investigational Site
London
W2 1NY
Wythenshawe
M23 9LT
Southampton General Hospital
Southampton
England
SO16 6YD
Birmingham
B15 2TH
King's College Hospital
London
SE5 9RS
Rheumatology Department, Poole Hospital NHS Trust
Poole
BH15 2JB
Clinical Trials Unit; Main Hospital; Salford Rooyal NHS Foundation Trust
Salford
M6 8HD
Chelsea and Westminster Hospital
London
SW10 9NH
Reading
RG1 5AN
Bristol
BS2 8HW
Royal Infirmary Edinburgh
Edinburgh
Scotland
EH3 9YW
GSK Investigational Site
Antrim
BT41 2RL
Centre for Experimental Medicine Queen's University Belfast
Belfast
Co.Antrim
BT12 6BA
Belfast
BT16 1RH
Broadgreen Hospital
Liverpool
L14 3LB
Investigational Site Number 826042
Londonderry
BT47 6SB
Trial Contact(s)
Primary Trial Contact
Dr Ronan McMullan
+44 2890 634140
Other Trial Contacts
Mr Paul Doherty
+44 2890 63 5794
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
PoinT of carE teSTing for sepsIs: a diagnosTic accuracy study
EudraCT Number
Sorry, this information is not available
Funder(s)
  • Innovate UK
Other Study ID Numbers
15176RMcM-SS
Sponsor(s)
Belfast Health and Social Care Trust (BHSCT)
Key Dates

Recruitment Start Date

01 Sep 2016

Recruitment End Date

28 Feb 2018

Trial Start Date

01 May 2015

Trial End Date

28 Feb 2018

Date added to source

18 Aug 2016

Date updated in source

10 Nov 2017