Evaluation of antibiotic use in coronavirus (COVID-19) hospitalised patients
| ISRCTN | ISRCTN66682918 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66682918 |
| Secondary identifying numbers | v1.2 |
- Submission date
- 14/01/2021
- Registration date
- 17/05/2021
- Last edited
- 12/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
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 |
| J.sandoe@leeds.ac.uk |
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 |
| edcarrol@liverpool.ac.uk |
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 |
| EudenJ@cardiff.ac.uk |
Study information
| Study design | Mixed methods controlled time-series analysis, matched case control study, interview study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | No participant information sheet available |
| 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/10/2020 |
| Completion date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Patient-level data will be sourced from ~7000 COVID-19 patients from 11 NHS acute hospitals |
| 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
- England
- United Kingdom
- Wales
Study participating centres
Leeds
LS9 7TF
United Kingdom
Liverpool
L7 8XP
United Kingdom
Salford
Greter Manchester
M6 8HD
United Kingdom
Brighton
BN2 5BE
United Kingdom
Truro
TR1 3LJ
United Kingdom
Lodge Road
Caerleon
Newport
NP18 3XQ
United Kingdom
Sheffield
S5 7AU
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Bristol
BS10 5NB
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Aberford Road
Wakefield
WF1 4DG
United Kingdom
Sponsor information
University/education
Faculty Research Office
Room 9.29, Level 9
Worsley Building
Clarendon Way
Leeds
LS2 9NL
England
United Kingdom
| Phone | +44 (0)1133437587 |
|---|---|
| governance-ethics@leeds.ac.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Research findings will be disseminated through publications and reports submitted via a variety of audiences, such as NICE, Public Health England, Public Health Wales, British Society of Antimicrobial Chemotherapy (global antibiotic charity), and the British Infection Association. |
| 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? |
|---|---|---|---|---|---|
| Protocol file | version v1.1 | 02/03/2021 | 17/05/2021 | No | No |
| 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 |
| Protocol file | version 1.2 | 25/08/2022 | 13/09/2022 | No | No |
| HRA research summary | 28/06/2023 | No | 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 |
| Statistical Analysis Plan | version 1.0 | 07/09/2022 | 14/03/2025 | No | No |
| Results article | Integrating the quantitative and qualitative data showed that PCT testing reduced antibiotic prescribing | 08/08/2025 | 12/08/2025 | Yes | No |
Additional files
Editorial Notes
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).
