Condition category
Infections and Infestations
Date applied
14/09/2020
Date assigned
17/12/2020
Last edited
16/12/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

http://www.batch-trial.co.uk

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

http://www.liv.ac.uk/

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

Publication citations

Additional files

Editorial Notes

17/09/2020: Trial's existence confirmed by the NIHR.