Condition category
Infections and Infestations
Date applied
06/09/2017
Date assigned
20/09/2017
Last edited
20/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Sepsis is defined as the body’s response to infection, which can often be indistinguishable from the response to other insults like burns or surgery. On one hand, giving antibiotics promptly saves lives, but on the other hand, giving antibiotics to people who do not need them leads to overuse of antibiotics and antimicrobial resistance. The Department of Health recommends that antibiotics should be given for as short a course as is safe, to prevent antimicrobial resistance. Most hospitals in the NHS use a blood test called C-Reactive Protein (CRP) to monitor response to infection, but it is not specific for bacterial infection and shows a delayed response to infection. Procalcitonin (PCT) is a blood test which is specific for bacterial infection and responds more quickly than CRP, but is not routinely used in the NHS. Studies done mainly in adults shows that using procalcitonin to guide clinicians may reduce the amount of antibiotics used, reduce hospital stay, and is not associated with adverse effects such as hospital re-admission, incomplete treatment of infections, relapse or death. A recent guideline from the National Institute for Health and Care Excellence (NICE) recommends further research on procalcitonin testing to guide antibiotic use in children. The aim of this study is to compare the current management of severe bacterial infection (SBI) in children (doctors use clinical judgement and may also use CRP to decide on duration of intravenous antibiotics) with procalcitonin-guided management, where the management is identical to current practice, except that doctors have an additional procalcitonin test with advice on how to interpret the result.

Who can participate?
Children aged 18 and younger who are admitted to the hospital for confirmed or suspected bacterial infection or sepsis.

What does the study involve?
Children hospitalised with suspected or confirmed bacterial infection are randomised to the intervention or control arm. In those randomised to the intervention arm, a Procalcitonin (PCT) test is performed in the hospital laboratory at baseline, days 3-5, days 6-14 and day 28 (if still on IV antibiotics). The PCT results feed into an algorithm that guides antimicrobial prescribing decisions. Children in the control arm do not have the PCT test performed and receive care as usual. Participants are followed up at day 28 with a telephone call or electronic follow up to ask about the quality of life of the children and healthcare utilisation.

What are the possible benefits and risks of participating?
The benefit of taking part is that the information collected will help children/young people in the future.
Taking part in the trial will mean giving up some time during the child's hospital stay and at the follow up telephone call.

Where is the study run from?
This study is being run by the University of Liverpool (UK) and takes place in children’s hospitals in the UK.

When is the study starting and how long is it expected to run for?
September 2017 to August 2020

Who is funding the study?
NIHR HTA Programme

Who is the main contact?
Dr Cherry-Ann Waldron

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

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UoL001333

Study information

Scientific title

Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection

Acronym

BATCH

Study hypothesis

The aim of this study is to determine if the addition of Procalcitonin (PCT) testing to current best practice based on the NICE Antimicrobial Stewardship (AMS) guidelines can safely allow a reduction in duration of antibiotic therapy in hospitalised children with suspected or confirmed bacterial infection compared to current best practice alone.

Ethics approval

Not provided at time of registration

Study design

Prospective two-armed individually randomised controlled trial (RCT)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Bacterial infection

Intervention

Children hospitalised with suspected or confirmed bacterial infection are randomised to the intervention or control arm. In those randomised to the intervention arm, a Procalcitonin (PCT) test is performed in the hospital laboratory at baseline, days 3-5, days 6-14 and day 28 (if still on IV antibiotics). The PCT results feed into an algorithm that guides antimicrobial prescribing decisions. Children in the control arm do not have the PCT test performed and receive care as usual.

At Day 28, participants receive a telephone or electronic follow up with the parent to ask about the healthcare utilisation and quality of life of the child.

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

1. Antibiotics use is measured using the number of days IV antibiotics are used
2. Safety is measured as the number of patients experiencing one of:
2.1. Unscheduled admissions/re-admissions (to include readmission rate within 7 days of discharge with infective diagnosis, unscheduled readmission to PICU with infective diagnosis, or admission to PICU with infective diagnosis)
2.2. Re-treatment for same condition within 7 days of stopping IV antibiotics (re-starting IV antibiotics which have been stopped),
2.3. Mortality

Secondary outcome measures

1. Total duration of antibiotics (IV and oral)
2. Unscheduled admissions/re-admissions (to include readmission rate within 7 days of discharge with infective diagnosis, unscheduled readmission to PICU with infective diagnosis, or admission to PICU with infective diagnosis.)
3. Re-treatment for same condition within 7 days of stopping IV antibiotics (re-starting IV antibiotics which have been stopped)
4. Time to switch from broad spectrum to narrow spectrum antibiotics
5. Time to discharge from hospital
6. Suspected Adverse Drug Reactions (ADR) is measured using the Liverpool Causality Assessment Tool.
7. Cost of hospital episode is measured using cost analysis.
8. Hospital Acquired Infection (HAI) is measured using up to Day 28
9. Health utility is measured using CHU9D (for children aged 5 and above) up to Day 28.
10 Mortality.

Outcome data is recorded daily by the research nurse for all recruited participants (up to and including Day 28, or until discharge). Research nurses review observation and medication charts, medical notes for all recruited participants.

Overall trial start date

01/09/2017

Overall trial end date

31/08/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. All children up to 18 years old admitted to hospital for confirmed or suspected bacterial infection or sepsis, in whom IV antibiotics are commenced, and expected to remain on IV antibiotics for at least 48 hours
2. Conditions include: bacteraemia, bone and joint infections, discitis, empyema, pneumonia, pyelonephritis, sinusitis, retropharyngeal abscess, pyomyositis, uncomplicated culture-negative meningitis, intra-abdominal infections, lymphadenitis, cellulitis, bacterial endocarditis

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1942

Participant exclusion criteria

1. Preterm infant age <37 weeks corrected gestational age or ≥18 years of age
2. Children admitted moribund and not expected to survive more than 24 hours
3. Children with a predicted duration of stay of less than 48 hours
4. Children not expected to survive at least 28 days because of pre-existing condition
5. Bacterial meningitis, Bacterial endocarditis, Brain abscess
6. Children receiving antibiotics for surgical prophylaxis
7. Chronic co-morbidities, such as cystic fibrosis, chronic lung disease, bronchiectasis
8. Severe immunocompromised (e.g. chemotherapy, stem cell transplant, biological therapy for inflammatory or rheumatological conditions, TPN dependent)
9. Presence of existing directive to withhold life-sustaining treatment

Recruitment start date

01/01/2018

Recruitment end date

31/12/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Alder Hey Children's NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom

Trial participating centre

Noah's Ark Children's Hospital for Wales
Heath Park Way
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Bristol Royal Hospital for Children
24 Upper Maudlin Street
Bristol
BS2 8BJ
United Kingdom

Trial participating centre

University Hospital Southampton NHS Foundation Trust
Tremona Road
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Sheffield Children's NHS Foundation Trust
Western Bank
Sheffield
S10 2TH
United Kingdom

Trial participating centre

Royal Hospital for Children, Glasgow
1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Trial participating centre

The Royal Hospital for Sick Children, Edinburgh
9 Sciennes Road
Edinburgh
EH9 1LF
United Kingdom

Trial participating centre

Royal Manchester Children's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Pennine Acute Hosptials NHS Trust
Delaunays Road
Crumpsall
M8 5RB
United Kingdom

Sponsor information

Organisation

University of Liverpool

Sponsor details

Research Support Office
2nd Floor Block D
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR HTA Programme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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 are/will be available upon request from opendata@cardiff.ac.uk – this would be 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

01/09/2021

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes