Using procalcitonin to guide duration of antibiotics - further evaluation of the effectiveness
| ISRCTN | ISRCTN14945050 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14945050 |
| IRAS number | 235042 |
| Secondary identifying numbers | CPMS 47548, IRAS 235042, UoL001333 |
- Submission date
- 14/09/2020
- Registration date
- 17/12/2020
- Last edited
- 12/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
In the BATCH trial (https://www.isrctn.com/ISRCTN11369832), researchers are looking at a blood marker for a 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 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 infections 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 August 2024
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
Contact information
Public
Centre for Trials Research
College of Biomedical & Life Sciences
Cardiff University
7th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
 ORCID ID |
0000-0001-8465-2492 |
|---|---|
| Phone | +44 (0)2929 687609 |
| waldronc@cardiff.ac.uk |
Scientific
University of Liverpool Institute of Infection and Global Health
Ronald Ross Building
8 West Derby Street
Liverpool
L69 7BE
United Kingdom
| Phone | +44 (0)151 794 9535 |
|---|---|
| edcarrol@liverpool.ac.uk |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | MR-PRo-adrenomedullin (MR-proADM) and ImmunoXpert Evaluation of procalcitonin-guided antibiotic duration in Children with Infection for Stratification of Effectiveness (PRECISE) |
| Study acronym | PRECISE |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2020 |
| Completion date | 01/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 266 |
| Total final enrolment | 407 |
| Key inclusion criteria | Same as the BATCH trial (ISRCTN11369832) |
| Key exclusion criteria | Same as the BATCH trial (ISRCTN11369832) |
| Date of first enrolment | 01/02/2021 |
| Date of final enrolment | 11/10/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Eaton Road
Liverpool
L12 2AP
United Kingdom
24 Upper Maudlin Street
Bristol
BS2 8BJ
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Oxford
OX3 9DU
United Kingdom
Sponsor information
University/education
Institute of Infection and Global Health
Ronald Ross Building
8 West Derby Street
Liverpool
L69 7BE
England
United Kingdom
| Phone | +44 (0)151 794 9535 |
|---|---|
| Sponsor@liverpool.ac.uk | |
| Website | http://www.liv.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Efficacy and Mechanism Evaluation Programme, EME
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | Current Individual participant data (IPD) sharing statement as of 09/02/2023: The datasets generated during the current study are available upon request from the Centre for Trials Research, Cardiff University by contacting the trial manager at BATCH@cardiff.ac.uk. Pseudo-anonymised data will be provided upon production of the requestor’s study protocol and agreement by Centre of Trials Research and study sponsor (University of Liverpool). _____ Previous Individual participant data (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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | SAP article | 30/05/2023 | 31/05/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
12/09/2024: The following changes were made:
1. The overall end date was changed from 30/06/2024 to 01/08/2024.
2. The intention to publish date was changed from 30/09/2024 to 01/02/2025.
3. The total final enrolment number was added.
17/01/2024: The following changes were made to the trial record:
1. The overall end date was changed from 11/10/2022 to 30/06/2024.
2. The intention to publish date was changed from 30/03/2024 to 30/09/2024.
3. The plain English summary was updated to reflect these changes.
08/11/2023: The following changes were made:
1. The overall study end date was changed from 11/10/2022 to 30/11/2023.
2. The intention to publish date was changed from 31/01/2024 to 30/03/2024.
10/07/2023: The intention to publish date was changed from 31/07/2023 to 31/01/2024.
09/02/2023: The participant-level data sharing statement was changed.
11/11/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/11/2022 to 11/10/2022.
2. The overall trial end date was changed from 30/06/2023 to 11/10/2022 and the plain English summary updated accordingly.
3. The intention to publish date was changed from 01/01/2024 to 31/07/2023.
14/09/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2022 to 30/11/2022.
2. The overall trial end date was changed from 30/11/2022 to 30/06/2023 and the plain English summary updated accordingly.
3. The intention to publish date was changed from 01/09/2023 to 01/01/2024.
13/07/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/07/2022 to 30/09/2022.
2. The overall trial end date has been changed from 30/09/2022 to 30/11/2022 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 01/09/2022 to 01/09/2023.
30/12/2021: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2021 to 31/07/2022.
2. The overall trial end date has been changed from 28/02/2022 to 30/09/2022 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from to.
01/02/2021: The recruitment end date was changed from 31/03/2021 to 31/12/2021.
17/09/2020: Trial's existence confirmed by the NIHR.
