Evaluation of antibiotic use in coronavirus (COVID-19) hospitalised patients

ISRCTN	ISRCTN66682918
DOI	https://doi.org/10.1186/ISRCTN66682918
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	v1.2
Sponsor	University of Leeds
Funder	National Institute for Health Research

Submission date: 14/01/2021
Registration date: 17/05/2021
Last edited: 06/11/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Antibacterial agents (antibiotics) are usually used during the treatment of patients with more severe COVID-19 even though COVID-19 is caused by a virus, and antibiotics don’t work against viruses. This is because doctors are concerned that there might be a bacterial infection on top of the viral infection, a so-called secondary infection, that is making matters worse. In fact, there is no good evidence to guide the use of antibiotics in COVID-19, and rates of secondary bacterial infection are thought to be low. The COVID-19 pandemic has therefore resulted in an unwanted increase in antibiotic use which will expose patients to more side effects, an increased risk of infection with superbugs, and increase costs.

This is a study about a blood test called procalcitonin (PCT) which is used in many hospitals to help diagnose bacterial infections and guide antibiotic treatment. There is a lack of clear evidence to support its use in lung infections, which means in some hospitals, clinicians have used the procalcitonin test to guide antibiotic decisions in COVID-19, whilst in other hospitals, they have not.

The PEACH study will analyse data from hospital trusts that did and did not use procalcitonin testing during the first wave of the COVID-19 pandemic. It will determine whether and how procalcitonin testing should be used in the NHS in future waves of COVID-19 to protect patients from antibiotic overuse.

Who can participate?
Patient-level data will be sourced from COVID-19 patients from 11 NHS acute hospitals

What does the study involve?
This study involves the analysis of data from before and during the first wave of the COVID-19 pandemic on the use of PCT testing by NHS trusts and hospitals from the antimicrobial pharmacist’s network, professional networks of infection and critical care specialists, providers of PCT testing resources, Rx Info Ltd, Public Health England, and Public Health Wales. The study will also analyse the use of PCT testing and clinical outcomes of COVID-19 patients from 11 NHS acute hospitals during the first wave of the pandemic.

What are the possible benefits and risks of participating?
This study looks only at historical data so no benefits or risks are anticipated.

Where is the study run from?
The University of Leeds (UK)

When is the study starting and how long is it expected to run for?
From October 2020 to December 2022

Who is funding the study?
The National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Unfortunately, this study is not recruiting public volunteers at this time. This is because the research isn’t ready for volunteers yet or the researchers are directly identifying volunteers in certain areas or hospitals. Please do not contact the research team as they will not be able to respond. For more information about COVID-19 research, visit the Be Part of Research homepage.

Contact information

Dr Jonathan Sandoe
Scientific

University of Leeds and Leeds Teaching NHS Trust
Department of Microbiology
Old Medical School
The General Infirmary at Leeds
Leeds
LS1 3EX
United Kingdom

ORCID ID	0000-0003-0193-8677
Phone	+44 (0)1133928783
Email	J.sandoe@leeds.ac.uk

Prof Enitan Carrol
Scientific

University of Liverpool
Institute of Infection and Global Health
8 West Derby Street
Liverpool
L69 7BE
United Kingdom

ORCID ID	0000-0001-8357-7726
Phone	+44 (0)7721315021
Email	edcarrol@liverpool.ac.uk

Dr Joanne Euden
Public

Centre for Trials Research
College of Biomedical and Life Sciences
Cardiff University
7th Floor
Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom

ORCID ID	0000-0002-2844-6878
Phone	No telephone contact provided
Email	EudenJ@cardiff.ac.uk

Study information

Primary study design	Observational
Study design	Mixed methods controlled time-series analysis, matched case control study, interview study
Secondary study design	Case-control study
Study type	Participant information sheet
Scientific title	PEACH: Evaluation of Antibiotic use in COVID-19 Hospitalised patients
Study acronym	PEACH
Study objectives	The use of procalcitonin (PCT) testing, to guide antibiotic prescribing, safely reduced antibiotic use among patients who were hospitalised with COVID-19 during the first wave of the pandemic.
Ethics approval(s)	Approved 03/03/21, West Midlands - Solihull Research Ethics Committee (The Old Chapel Royal Standard Place, Nottingham NG1 6FS; +44 (0)207 1048310; solihull.rec@hra.nhs.uk) Ref 21/WM/0052
Health condition(s) or problem(s) studied	COVID-19 (SARS-CoV-2 infection), COVID-19 hospitalised patients
Intervention	PEACH will assess whether the use of procalcitonin (PCT) testing, to guide antibiotic prescribing, safely reduced antibiotic use among patients who were hospitalised with COVID-19 during the first wave of the pandemic in the UK. This study will collect both trust-level and patient-level clinical data. Trust level data will be used to evaluate how widely PCT was used before the first COVID-19 wave, and the utilization of PCT testing to guide antibiotic prescribing during the first wave of COVID-19 pandemic in NHS hospital trusts caring for COVID-19 inpatients aged >16 years. Patient-level data will be used to evaluate the impact of PCT testing on antibiotic exposure and clinical outcome for COVID-19 patients. Trust level data will be collected from different sources to maximise completeness and accuracy. 1. How widely PCT was used before and after the first wave of the COVID-19 pandemic in the UK using: 1.1. A questionnaire distributed to the antimicrobial pharmacist’s network and through contacts within professional networks of infection and critical care specialists 1.2. Information from providers of testing resources 2.. Antibiotic consumption (Defined Daily Dose, by route and agent) between 01/03/2020 to 30/06/2020 using data gathered by Rx Info Ltd, Public Health England, and Public Health Wales. A retrospective observational analysis using propensity score matching will be used to assess the patient-level impact of PCT on antibiotic use and clinical outcomes. This analysis will use patient-level clinical data collected from 11 UK NHS trusts which did/did not use PCT routinely in COVID-19 patients aged >16 years. The patient-level cost of illness will be calculated from a secondary care NHS perspective from this data in a later stream of this study. Semi-structured interviews with health care professionals will be used to explore the decision-making process around the use of antibiotics, identify the contextual factors, explore the feasibility and acceptability of PCT testing algorithms, and identify the key ingredients of successful implementation and normalisation of PCT algorithms in the management of COVID-19.
Intervention type	Other
Primary outcome measure(s)	Current primary outcome measure as of 13/09/2022: 1. Change in level and/or trend of antibiotic prescribing rates following the introduction of PCT testing. Measures using the weekly trend of the number of defined daily doses (DDDs) of prespecified antibiotics commonly used for respiratory tract infection (‘CAP-DDD’) per number of COVID+ admissions collected by Rx Info Ltd, Public Health England, and Public Health Wales between 01/03/2020 and 30/06/2022 2. Length of early antibiotics therapy measured using patient-level data collected within the first 7 days of admission 3. Patient-level cost of illness from COVID-19 in NHS trusts measured using data gathered by Rx Info Ltd, Public Health England, and Public Health Wales at baseline and during the first 7 days of admission 4. Identifying and reviewing published evidence of cost-effectiveness 5. Cost-effectiveness of different PCT testing strategies in COVID-19 Previous primary outcome measure: 1. Antibiotic prescribing rates following the introduction of procalcitonin (PCT) testing measured using the number of defined daily doses (DDDs) of prespecified antibiotics commonly used for respiratory tract infection (CAP-DDD) per number of COVID+ hospital admissions collected by Rx Info Ltd, Public Health England, and Public Health Wales between 01/03/2020 to 30/06/2020 2. Length of early antibiotics therapy measured using patient-level data collected within the first 7 days of admission 3. Patient-level cost of illness from COVID-19 in NHS trusts measured using data gathered by Rx Info Ltd, Public Health England, and Public Health Wales at baseline and during the first 7 days of admission
Key secondary outcome measure(s)	Current secondary outcome measures as of 13/09/2022: 1. Number of CAP-DDDs per total number of admissions collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 2. Number of DDDs of all antibiotics (excluding anti TB) total DDDs (tDDDs) per number of COVID+ admissions collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 3. Number of tDDDs per total number of admissions collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 4. Number of CAP-DDDs per total number of patient bed days collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 5. Number of CAP-DDDs per number of COVID+ patient bed days collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 6. Number of tDDDs per total number of patient bed days collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 7. Number of tDDDs per number of COVID+ patient bed days collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 8. Total length of antibiotic treatment measured using patient-level data collected at baseline and during the first 7 days of admission 9. tDDDs of antibiotics measured using patient-level data collected at baseline and during the first 7 days of admission 10. Duration of late antibiotic treatment measured using patient-level data collected at baseline and during the first 7 days of admission 11. DDDs of late antibiotic treatment measured using patient-level data collected at baseline and during the first 7 days of admission 12. DDDs of early antibiotic treatment measured using patient-level data collected at baseline and during the first 7 days of admission 13. Appropriateness of antibiotics according to local guidelines (% compliance) if practicable measured using patient-level data collected at baseline and during the first 7 days of admission 14. 30-day mortality measured using patient-level data collected at 30 days 15. 60-day mortality measured using patient-level data collected at 60 days 16. ICU admission measured using patient-level data collected at baseline and during the first 7 days of admission 17. ICU length of stay measured using patient-level data collected at ICU discharge 18. Length of hospital stay measured using patient-level data collected at discharge 19. Antimicrobial-resistant secondary bacterial infection measured using patient-level data collected at baseline and during the first 7 days of admission 20. Descriptive outcomes including types of antibiotic, route of administration and duration, frequency of PCT testing, and types of secondary bacterial infection measured using patient-level data collected at baseline and during the first 7 days of admission 21. Decision-making process around using antibiotics for patients with COVID measured using patient notes collected at baseline and during the first 7 days of admission 22. Feasibility, acceptability, and implementation of PCT testing algorithms in the management of COVID-19 measured using patient notes collected at baseline and during the first 7 days of admission Previous secondary outcome measures: 1. Number of CAP-DDDs per total number of admissions collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 2. Number of DDDs of all antibiotics (excluding anti TB) total DDDs (tDDDs) per number of COVID+ admissions collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 3. Number of tDDDs per total number of admissions collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 4. Number of CAP-DDDs per total number of patient bed days collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 5. Number of CAP-DDDs per number of COVID+ patient bed days collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 6. Number of tDDDs per total number of patient bed days collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 7. Number of tDDDs per number of COVID+ patient bed days collected by Rx Info Ltd, Public Health England, and Public Health Wales to calculate weekly trends between 01/03/2020 to 30/06/2020 8. Total length of antibiotic treatment measured using patient-level data collected at baseline and during the first 7 days of admission 9. tDDDs of antibiotics measured using patient-level data collected at baseline and during the first 7 days of admission 10. Duration of late antibiotic treatment measured using patient-level data collected at baseline and during the first 7 days of admission 11. DDDs of late antibiotic treatment measured using patient-level data collected at baseline and during the first 7 days of admission 12. DDDs of early antibiotic treatment measured using patient-level data collected at baseline and during the first 7 days of admission 13. Appropriateness of antibiotics according to local guidelines (% compliance) if practicable measured using patient-level data collected at baseline and during the first 7 days of admission 14. 30-day mortality measured using patient-level data collected at 30 days 15. 60-day mortality measured using patient-level data collected at 60 days 16. ICU admission measured using patient-level data collected at baseline and during the first 7 days of admission 17. ICU length of stay measured using patient-level data collected at ICU discharge 18. Length of hospital stay measured using patient-level data collected at discharge 19. Acute kidney injury measured using patient-level data collected at baseline and during the first 7 days of admission 20 Antimicrobial-resistant secondary bacterial infection measured using patient-level data collected at baseline and during the first 7 days of admission 21. Descriptive outcomes including types of antibiotic, route of administration and duration, frequency of PCT testing, and types of secondary bacterial infection measured using patient-level data collected at baseline and during the first 7 days of admission 22. Decision-making process around using antibiotics for patients with COVID measured using patient notes collected at baseline and during the first 7 days of admission 23. Feasibility, acceptability, and implementation of PCT testing algorithms in the management of COVID-19 measured using patient notes collected at baseline and during the first 7 days of admission
Completion date	31/12/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	7000
Total final enrolment	6132
Key inclusion criteria	Trust-level clinical data: 1. NHS hospital trust caring for COVID-19 inpatients aged >16 years Patient-level clinical data: 1. Confirmed COVID-19 infection 2. Admitted to participating trust for any reason
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/03/2020
Date of final enrolment	30/06/2020

Locations

Countries of recruitment

United Kingdom
England
Wales

Study participating centres

Leeds Teaching Hospitals NHS Trust

Beckett Street
Leeds
LS9 7TF
United Kingdom

Royal Liverpool University Hospital

Prescot Street
Liverpool
L7 8XP
United Kingdom

Salford Royal Infirmary

Stott Lane
Salford
Greter Manchester
M6 8HD
United Kingdom

Royal Sussex County Hospital

Eastern Road
Brighton
BN2 5BE
United Kingdom

Royal Cornwall Hospital

Treliske
Truro
TR1 3LJ
United Kingdom

St Cadoc's Hospital

Aneurin Bevan University Health Board
Lodge Road
Caerleon
Newport
NP18 3XQ
United Kingdom

Northern General Hospital

Herries Road
Sheffield
S5 7AU
United Kingdom

Freeman Hospital

Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Southmead Hospital

Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Queens Medical Centre

Nottingham University Hospitals NHS Trust
Derby Road
Nottingham
NG7 2UH
United Kingdom

Pindersfield Hospital

Mid Yorkshire Hospitals NHS Trust
Aberford Road
Wakefield
WF1 4DG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Cardiff Centre for Trials Research by contacting the study manager (Dr Joanne Euden) at PEACH@cardiff.ac.uk. Anonymised data will be provided upon production of the requestor’s study protocol and agreement by Centre of Trials Research and study sponsor (Leeds University).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	controlled interrupted time series analysis of organization-level data	08/02/2022	25/03/2022	Yes	No
Results article	retrospective observational study results	01/05/2021	25/03/2022	Yes	No
Results article	decision-making processes during the first wave of the COVID-19 pandemic	19/12/2023	08/01/2024	Yes	No
Results article	A retrospective propensity-score-matched cohort study of the impact of procalcitonin testing on antibiotic use in hospitalized patients during the first wave of COVID-19	09/09/2024	10/09/2024	Yes	No
Results article	Integrating the quantitative and qualitative data showed that PCT testing reduced antibiotic prescribing	08/08/2025	12/08/2025	Yes	No
Results article	Procalcitonin evaluation of antibiotic use in COVID-19 hospitalised patients: The PEACH mixed methods study	01/11/2025	06/11/2025	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version v1.1	02/03/2021	17/05/2021	No	No
Protocol file	version 1.2	25/08/2022	13/09/2022	No	No
Statistical Analysis Plan	version 1.0	07/09/2022	14/03/2025	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN66682918_PROTOCOL_v1.1_02March21.pdf: Uploaded 17/05/2021
ISRCTN66682918_Protocol_V1.2_25Aug22.pdf: Protocol file
ISRCTN66682918 PEACH_WP2_1_SAP.pdf: Statistical Analysis Plan

Editorial Notes

06/11/2025: Publication reference added.
12/08/2025: Publication reference added.
14/03/2025: The statistical analysis plan was uploaded as an additional file.
10/09/2024: Publication reference added.
08/01/2024: Publication reference added.
04/01/2023: Total final enrolment was added.
13/09/2022: The following changes have been made:
1. The protocol (not peer reviewed) has been uploaded as an additional file and the protocol /serial number has been updated to reflect this change.
2. The primary outcome measure has been updated.
3. The secondary outcome measures have been updated.
25/03/2022: Publication reference added.
09/03/2022: The following changes have been made:
1. The ethics approval has been added.
2. The overall trial end date has been changed from 31/03/2022 to 31/12/2022 and the plain English summary has been updated to reflect this change.
17/05/2021: Uploaded protocol Version 1.1, 02 March 2021 (not peer reviewed).
25/01/2021: Trial’s existence confirmed by the National Institute for Health Research (NIHR).