Plain English Summary
Background and study aims
In the BATCH trial, researchers are looking at a blood marker for bacterial infection called procalcitonin to see if it can help to identify how children and young people are responding to antibiotics that are being used to treat the infection. In this study, the researchers would like to see if two other blood markers called MR-PRo-adrenomedullin (MR-proADM) and ImmunoXpert can also help provide information that will help treat children and young people with bacterial infection in the future.
Who can participate?
Participants recruited into the BATCH trial
What does the study involve?
The researchers would like to collect additional samples of a small amount of blood (0.5-1 ml) from the children and young people recruited into the BATCH trial. They will try to take these samples at the same time as routine blood tests are being taken, or use the leftover blood that is normally discarded by the laboratory after the routine tests are done. However, they may need to take an additional blood test at separate time points if routine bloods are not due to be collected or there is not enough routine blood leftover. The researchers will always ask permission first and will use the method of collection that participants prefer, such as finger prick, vein or arterial line (if this is already in place).
What are the possible benefits and risks of participating?
Participants will be helping to provide information that will help treat children and young people with bacterial infection in the future. They will be given a £20 high street shopping voucher for the inconvenience of participating in the study, which is unconditional and not dependent on giving permission for any additional samples to be taken.
Where is the study run from?
The study is led by the University of Liverpool and managed by the Centre for Trials Research at Cardiff University (UK)
When is the study starting and how long is it expected to run for?
September 2020 to February 2022
Who is funding the study?
National Institute for Health Research Efficacy and Mechanism Evaluation (NIHR EME) Programme (UK)
Who is the main contact?
Dr Cherry-Ann Waldron
waldronc@cardiff.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Dr Cherry-Ann Waldron
ORCID ID
http://orcid.org/0000-0001-8465-2492
Contact details
Centre for Trials Research
College of Biomedical & Life Sciences
Cardiff University
7th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
+44 (0)2929 687609
waldronc@cardiff.ac.uk
Type
Scientific
Additional contact
Prof Enitan Carrol
ORCID ID
Contact details
University of Liverpool Institute of Infection and Global Health
Ronald Ross Building
8 West Derby Street
Liverpool
L69 7BE
United Kingdom
+44 (0)151 794 9535
edcarrol@liverpool.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 47548, IRAS 235042, UoL001333
Study information
Scientific title
MR-PRo-adrenomedullin (MR-proADM) and ImmunoXpert Evaluation of procalcitonin-guided antibiotic duration in Children with Infection for Stratification of Effectiveness (PRECISE)
Acronym
PRECISE
Study hypothesis
The aim of the PRECISE study is to determine if there are specific sub-groups of patients for whom a PCT-guided antibiotic algorithm may be beneficial, harmful or ineffective. It aims to identify endotypes or sub-phenotypes of infection to facilitate optimisation of antibiotic dosing and duration (when, by how much and for how long). The embedded mechanistic study within an existing RCT allows the theranostic exploration of two commercially available biomarker assays to guide judicious antibiotic use.
Ethics approval
Approved 13/04/2018, North West Liverpool East Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)2071048199; liverpoolcentral.rec@hra.nhs.uk), REC ref: 18/NW/0100
Study design
Embedded mechanism of action study within the BATCH trial (ISRCTN11369832) (a multi-centre, prospective, individually randomised, open-label two-arm randomized controlled trial comparing a PCT-guided antibiotic algorithm versus usual care)
Primary study design
Observational
Secondary study design
Embedded mechanism of action study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Bacterial infection
Intervention
MR-proADM and ImmunoXpert analysis of blood samples of children recruited to the BATCH trial (ISRCTN11369832) who have been hospitalised with suspected or confirmed bacterial infection, randomised to the intervention arm (e.g. procalcitonin test results that feed into an algorithm that guides antimicrobial prescribing conditions) or the control arm (usual care, no PCT test).
Intervention type
Other
Phase
Drug names
Primary outcome measure
Collected from patient notes up to and including day 28, or until discharge:
1. Time until IV antibiotic therapy is stopped
2. MR-proADM and ImmunoXpert scores at baseline will define subgroups for the primary comparison, and serial measurements for additional analyses
Secondary outcome measures
Collected from patient notes up to and including day 28, or until discharge:
1. Total duration of antibiotics (oral and IV)
2. Time to switch from broad-spectrum to narrow-spectrum antibiotics
3. Time to discharge from hospital
4. Suspected adverse drug reactions measured using the Liverpool Causality Assessment tool
5. Hospital-acquired infection up to Day 28
Overall trial start date
01/11/2020
Overall trial end date
28/02/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Same as the BATCH trial (ISRCTN1139832)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
266
Participant exclusion criteria
Same as the BATCH trial (ISRCTN1139832)
Recruitment start date
01/02/2021
Recruitment end date
31/03/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Alder Hey Children's Hospital
Alder Hey Children's NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom
Trial participating centre
Bristol Royal Hospital for Children
University Hospitals Bristol NHS Foundation Trust
24 Upper Maudlin Street
Bristol
BS2 8BJ
United Kingdom
Trial participating centre
Southampton Children's Hospital, University Hospital Southampton
University Hospital Southampton NHS Foundation Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom
Trial participating centre
Children’s Hospital, John Radcliffe Hospital
Oxford University Hospitals NHS Foundation Trust
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
University of Liverpool
Sponsor details
Institute of Infection and Global Health
Ronald Ross Building
8 West Derby Street
Liverpool
L69 7BE
United Kingdom
+44 (0)151 794 9535
Sponsor@liverpool.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Efficacy and Mechanism Evaluation Programme
Alternative name(s)
NIHR Efficacy and Mechanism Evaluation Programme, EME
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The trialists intend to publish the main trial results in international peer-reviewed journals and present at national and international scientific meetings. A protocol paper will be submitted for publication. Additional documentation will be available upon request.
IPD sharing statement
The datasets generated during and/or analysed during the current study will be available upon request from opendata@cardiff.ac.uk at the end of the study. The aim is to make the research data available wherever possible, subject to regulatory approvals, any terms and conditions from external providers, patient confidentiality and all laws concerning the protection of personal information. Data is generally freely available, but recipients are expected to acknowledge the original creators in any public use of the data or in publishing research results based wholly or in part upon the data – anyone requesting access to data will be asked to agree to the terms of the Creative Commons Attribution 4.0 license. The trialists may ask the requestor to cover reasonable cost for preparing and providing the data (for example physical storage and postage, where dataset size makes it impractical to provide data by electronic means).
Intention to publish date
01/09/2022
Participant level data
Available on request
Basic results (scientific)
Publication list