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Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (BATCH): protocol for a randomised controlled trial

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Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (BATCH): protocol for a randomised controlled trial. / Waldron, C.-A.; Thomas-Jones, E.; Bernatoniene, J. et al.
In: BMJ Open, Vol. 12, No. 1, e047490, 25.01.2022.

Research output: Contribution to Journal/MagazineJournal articlepeer-review

Harvard

Waldron, C-A, Thomas-Jones, E, Bernatoniene, J, Brookes-Howell, L, Faust, SN, Harris, D, Hinds, L, Hood, K, Huang, C, Mateus, C, Pallmann, P, Patel, S, Paulus, S, Peak, M, Powell, C, Preston, J & Carrol, ED 2022, 'Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (BATCH): protocol for a randomised controlled trial', BMJ Open, vol. 12, no. 1, e047490. https://doi.org/10.1136/bmjopen-2020-047490

APA

Waldron, C-A., Thomas-Jones, E., Bernatoniene, J., Brookes-Howell, L., Faust, S. N., Harris, D., Hinds, L., Hood, K., Huang, C., Mateus, C., Pallmann, P., Patel, S., Paulus, S., Peak, M., Powell, C., Preston, J., & Carrol, E. D. (2022). Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (BATCH): protocol for a randomised controlled trial. BMJ Open, 12(1), Article e047490. https://doi.org/10.1136/bmjopen-2020-047490

Vancouver

Waldron C-A, Thomas-Jones E, Bernatoniene J, Brookes-Howell L, Faust SN, Harris D et al. Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (BATCH): protocol for a randomised controlled trial. BMJ Open. 2022 Jan 25;12(1):e047490. doi: 10.1136/bmjopen-2020-047490

Author

Bibtex

@article{0f1069e9fe20435cb2a1e014629c6696,
title = "Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (BATCH): protocol for a randomised controlled trial",
abstract = "INTRODUCTION: Procalcitonin (PCT) is a biomarker more specific for bacterial infection and responds quicker than other commonly used biomarkers such as C reactive protein, but is not routinely used in the National Health Service (NHS). Studies mainly in adults show that using PCT to guide clinicians may reduce antibiotic use, reduce hospital stay, with no associated adverse effects such as increased rates of hospital re-admission, incomplete treatment of infections, relapse or death. A review conducted for National Institute for Health and Care Excellence recommends further research on PCT testing to guide antibiotic use in children. METHODS AND ANALYSIS: Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection is a multi-centre, prospective, two-arm, individually Randomised Controlled Trial (RCT) with a 28-day follow-up and internal pilot. The intervention is a PCT-guided algorithm used in conjunction with best practice. The control arm is best practice alone. We plan to recruit 1942 children, aged between 72 hours and up to 18 years old, who are admitted to the hospital and being treated with intravenous antibiotics for suspected or confirmed bacterial infection. Coprimary outcomes are duration of antibiotic use and a composite safety measure. Secondary outcomes include time to switch from broad to narrow spectrum antibiotics, time to discharge, adverse drug reactions, health utility and cost-effectiveness. We will also perform a qualitative process evaluation. Recruitment commenced in June 2018 and paused briefly between March and May 2020 due to the COVID-19 pandemic. ETHICS AND DISSEMINATION: The trial protocol was approved by the HRA and NHS REC (North West Liverpool East REC reference 18/NW/0100). We will publish the results in international peer-reviewed journals and present at scientific meetings. TRIAL REGISTRATION NUMBER: ISRCTN11369832. ",
keywords = "diagnostic microbiology, infectious diseases, paediatric intensive & critical care, public health, antiinfective agent, biological marker, adult, aged, bacterial infection, child, human, multicenter study (topic), randomized controlled trial (topic), Adult, Aged, Anti-Bacterial Agents, Bacterial Infections, Biomarkers, Child, COVID-19, Humans, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, SARS-CoV-2",
author = "C.-A. Waldron and E. Thomas-Jones and J. Bernatoniene and L. Brookes-Howell and S.N. Faust and D. Harris and L. Hinds and K. Hood and C. Huang and C. Mateus and P. Pallmann and S. Patel and S. Paulus and M. Peak and C. Powell and J. Preston and E.D. Carrol",
year = "2022",
month = jan,
day = "25",
doi = "10.1136/bmjopen-2020-047490",
language = "English",
volume = "12",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection (BATCH)

T2 - protocol for a randomised controlled trial

AU - Waldron, C.-A.

AU - Thomas-Jones, E.

AU - Bernatoniene, J.

AU - Brookes-Howell, L.

AU - Faust, S.N.

AU - Harris, D.

AU - Hinds, L.

AU - Hood, K.

AU - Huang, C.

AU - Mateus, C.

AU - Pallmann, P.

AU - Patel, S.

AU - Paulus, S.

AU - Peak, M.

AU - Powell, C.

AU - Preston, J.

AU - Carrol, E.D.

PY - 2022/1/25

Y1 - 2022/1/25

N2 - INTRODUCTION: Procalcitonin (PCT) is a biomarker more specific for bacterial infection and responds quicker than other commonly used biomarkers such as C reactive protein, but is not routinely used in the National Health Service (NHS). Studies mainly in adults show that using PCT to guide clinicians may reduce antibiotic use, reduce hospital stay, with no associated adverse effects such as increased rates of hospital re-admission, incomplete treatment of infections, relapse or death. A review conducted for National Institute for Health and Care Excellence recommends further research on PCT testing to guide antibiotic use in children. METHODS AND ANALYSIS: Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection is a multi-centre, prospective, two-arm, individually Randomised Controlled Trial (RCT) with a 28-day follow-up and internal pilot. The intervention is a PCT-guided algorithm used in conjunction with best practice. The control arm is best practice alone. We plan to recruit 1942 children, aged between 72 hours and up to 18 years old, who are admitted to the hospital and being treated with intravenous antibiotics for suspected or confirmed bacterial infection. Coprimary outcomes are duration of antibiotic use and a composite safety measure. Secondary outcomes include time to switch from broad to narrow spectrum antibiotics, time to discharge, adverse drug reactions, health utility and cost-effectiveness. We will also perform a qualitative process evaluation. Recruitment commenced in June 2018 and paused briefly between March and May 2020 due to the COVID-19 pandemic. ETHICS AND DISSEMINATION: The trial protocol was approved by the HRA and NHS REC (North West Liverpool East REC reference 18/NW/0100). We will publish the results in international peer-reviewed journals and present at scientific meetings. TRIAL REGISTRATION NUMBER: ISRCTN11369832.

AB - INTRODUCTION: Procalcitonin (PCT) is a biomarker more specific for bacterial infection and responds quicker than other commonly used biomarkers such as C reactive protein, but is not routinely used in the National Health Service (NHS). Studies mainly in adults show that using PCT to guide clinicians may reduce antibiotic use, reduce hospital stay, with no associated adverse effects such as increased rates of hospital re-admission, incomplete treatment of infections, relapse or death. A review conducted for National Institute for Health and Care Excellence recommends further research on PCT testing to guide antibiotic use in children. METHODS AND ANALYSIS: Biomarker-guided duration of Antibiotic Treatment in Children Hospitalised with confirmed or suspected bacterial infection is a multi-centre, prospective, two-arm, individually Randomised Controlled Trial (RCT) with a 28-day follow-up and internal pilot. The intervention is a PCT-guided algorithm used in conjunction with best practice. The control arm is best practice alone. We plan to recruit 1942 children, aged between 72 hours and up to 18 years old, who are admitted to the hospital and being treated with intravenous antibiotics for suspected or confirmed bacterial infection. Coprimary outcomes are duration of antibiotic use and a composite safety measure. Secondary outcomes include time to switch from broad to narrow spectrum antibiotics, time to discharge, adverse drug reactions, health utility and cost-effectiveness. We will also perform a qualitative process evaluation. Recruitment commenced in June 2018 and paused briefly between March and May 2020 due to the COVID-19 pandemic. ETHICS AND DISSEMINATION: The trial protocol was approved by the HRA and NHS REC (North West Liverpool East REC reference 18/NW/0100). We will publish the results in international peer-reviewed journals and present at scientific meetings. TRIAL REGISTRATION NUMBER: ISRCTN11369832.

KW - diagnostic microbiology

KW - infectious diseases

KW - paediatric intensive & critical care

KW - public health

KW - antiinfective agent

KW - biological marker

KW - adult

KW - aged

KW - bacterial infection

KW - child

KW - human

KW - multicenter study (topic)

KW - randomized controlled trial (topic)

KW - Adult

KW - Aged

KW - Anti-Bacterial Agents

KW - Bacterial Infections

KW - Biomarkers

KW - Child

KW - COVID-19

KW - Humans

KW - Multicenter Studies as Topic

KW - Randomized Controlled Trials as Topic

KW - SARS-CoV-2

U2 - 10.1136/bmjopen-2020-047490

DO - 10.1136/bmjopen-2020-047490

M3 - Journal article

VL - 12

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 1

M1 - e047490

ER -