Condition category
Infections and Infestations
Date applied
02/11/2016
Date assigned
07/11/2016
Last edited
07/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The number of infections caused by bacteria resistant to a range of antibiotics is increasing rapidly and treatment of some infections is becoming difficult. The greatest risk is in critically ill patients in the intensive care unit. Most of those patients are given antibiotics as a precautionary measure to avoid infection. If the antibiotics are not needed and can be stopped however, the risk of the patient developing infections that are resistant to antibiotics later can be reduced. If a test could rule out the presence of bacteria in the blood within 24 hours, the doctor may be able to stop antibiotic treatment at 24 or 48 hours

Who can participate?
Adults in ICU who are having blood samples taken to test for a suspected infection.

What does the study involve?
All participants have an additional blood sample taken when they are having routine samples taken. This sample is then tested in the lab using a kit that can show there are no bacteria in the sample. After 24 and 48 hours, the treating doctor is asked whether or not the information gained from the test would change the length of time antibiotics are given to that patient for.

What are the possible benefits and risks of participating?
A possible benefit may be having an increased chance of detecting infections in patient samples, as an additional sample is taken. There are no risks associated with the study.

Where is the study run from?
University College London Hospital (UK)

When is the study starting and how long is it expected to run for?
January 2016 to December 2017

Who is funding the study?
Momentum Bioscience Ltd (UK)

Who is the main contact?
Dr Andrew Peter Wilson
peter.wilson@uclh.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Peter Wilson

ORCID ID

Contact details

Clinical Microbiology & Virology
University College London Hospitals NHS Foundation Trust
60 Whitfield Street
London
W1T 4EU
United Kingdom
+44 20 3447 9516
peter.wilson@uclh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31765

Study information

Scientific title

Observational study in critical care to assess if use of a diagnostic test to exclude bacteremia would affect clinical decision making

Acronym

Study hypothesis

The aim of this study is to compare the performance of Enzymatic Template Generation & Amplification (ETGA) to conventional clinical and microbiological evaluation in determining length of antibiotic treatment in patients in the critical care unit.

Ethics approval

Wales Research Ethics Committee 4, 09/09/2016, ref: 16/WA/0264

Study design

Non-randomised; Both; Design type: Diagnosis, Device, Validation of investigation /therapeutic procedures

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Critical care, Primary sub-specialty: Critical care; UKCRC code/ Disease: Inflammatory and Immune System/ Other diseases of blood and blood-forming organs, Infection/ Bacterial, viral and other infectious agents

Intervention

All patients will be monitored during their stay in ICU up to five days from the first blood culture i.e. to the time of the final blood culture report. On the first day two blood samples will be taken for culture. One is managed as a routine blood culture in the main laboratory. The other is incubated for the Cognitor© Minus test. The blood culture bottles collected for the Cognitor© Minus test will be handled and incubated with the routine blood culture bottles. If there is bacterial growth in either of these blood cultures, the blood will be analysed to identify the organism(s) and the results made available for clinical management.

After 24 and 48 hours, the intensive care consultant is asked if the result of the test had indicated no bacteria in the original blood culture would he/she have discontinued antibiotics.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Whether the clinician’s decision on continuing antibiotic would have been affected by the test result if it had been available is assessed through clinician interviews at 24 and 48 hours.

Secondary outcome measures

Number of defined daily doses of antibiotic that would have been saved if the clinician had decided to stop antibiotics upon receiving a negative test result is determined by reviewing the patient’s current antibiotic treatment and expected duration at 24 or 48 hours.

Overall trial start date

07/01/2016

Overall trial end date

31/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patient has blood culture taken in critical care unit
2. Age >18 years
3. Not palliative treatment
4. Discharge expected within 48 hours
5. Death not imminent
6. Blood culture positive <12 hours
7. Test cannot be completed on the day sample taken

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

Participant exclusion criteria

1. Patient < 18 years of age
2. The treatment intent is palliative; the clinician is not committed to aggressive treatment
3. Treating clinician expects the patient to be discharged from the ICU on the day of evaluation (i.e. assessment for inclusion) or the following day
4. Death is deemed imminent and inevitable

Recruitment start date

15/11/2016

Recruitment end date

30/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London Hospital
235 Euston Road Fitzrovia
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

University College London Hospitals NHS Foundation Trust

Sponsor details

250 Euston Road
London
NW1 2PG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Momentum Bioscience Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results will be published in peer reviewed journals and presented at national and international conferences during 2018. Results will also be disseminated via patient groups.

IPD Sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

31/07/2018

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes