A study of multidrug resistant organisms in the adult intensive care unit at Addenbrooke's Hospital

ISRCTN	ISRCTN13493757
DOI	https://doi.org/10.1186/ISRCTN13493757
IRAS number	180415
Secondary identifying numbers	CUH R&D ref: A093680, IRAS 180415

Submission date: 13/02/2020
Registration date: 20/02/2020
Last edited: 06/03/2020

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Healthcare-associated infections (HCAI) affect up to 10% of hospital patients, and are associated with an increased risk of death. Multidrug-resistant organisms (MDRO) are more common in hospitals. Patients in intensive care units (ICU) are particularly vulnerable to HCAI, and several outbreaks of infection with MDRO have been reported.

Current practices for screening for MDRO vary between countries, hospitals and units, reflecting a lack of information, and uncertainty about best practice. One strategy to reduce HCAI in ICUs would be to perform screening to look for MDRO in patients admitted to ICUs. This would enable earlier identification and treatment of MDRO and implementation of appropriate infection control measures to prevent their spread.

Whole-genome sequencing (WGS) is novel technology, which is more discriminatory than currently available typing methods. We are conducting a study to determine the rates of carriage, infection, and transmission of MDRO in the adult ICU at Addenbrooke’s Hospital, using WGS. This study will facilitate translation of this technology from a research tool into day-to-day clinical practice. Information from this study will be used to inform infection control and public health policies and procedures.

Who can participate?
Any adult admitted to the John Farman Intensive Care Unit during the study period.

What does the study involve?
All patients admitted to ICU during the study period will be screened for MDRO and clinical data on infections and antimicrobial use will be collected.

What are the possible benefits and risks of participating?
No direct benefits for study participation. In terms of the risks of participation in the study, these are negligible as the study is observational in nature and there are no study-specific interventions or treatments. All specimens will be collected by experienced nursing staff, in accordance with routine clinical practice.

Where is the study run from?
Cambridge Biomedical Campus (UK)

When is the study starting and how long is it expected to run for?
June 2016 to December 2016

Who is funding the study?
1. Academy of Medical Sciences (UK)
2. The Health Foundation (UK)
3. National Institutes of Health Research Cambridge Biomedical Research Centre (UK)

Who is the main contact?
Dr Estee Torok
et317@cam.ac.uk

Contact information

Dr Estee Torok
Scientific

University of Cambridge, Department of Medicine, Box 157, Addenbrooke's Hospital, Hills Road
Cambridge
CB1 7TP
United Kingdom

ORCID ID	0000-0001-9098-8590
Phone	01223 336845
Email	et317@cam.ac.uk

Study information

Study design	Observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Whole-genome sequencing to investigate colonisation and transmission of multidrug-resistant organisms in the adult intensive care unit at Addenbrooke’s Hospital
Study acronym	ICU001
Study objectives	What is the prevalence of the colonisation and is there evidence of transmission of multidrug-resistant organisms in the adult intensive care unit?
Ethics approval(s)	Approved 21/04/2016, NHS Health Research Authority, East of England - Cambridge Central Research Ethics Committee (Royal Standard Place, Nottingham NG1 6FS, UK; +44 (0)207 104 8388; NRESCommittee.EastofEngland-CambridgeCentral@nhs.net), ref: 15/EE/0318
Health condition(s) or problem(s) studied	Surveillance for multidrug-resistant organisms
Intervention	All patients admitted to ICU during the study period will be screened for MDRO and clinical data on infections and antimicrobial use will be collected. Participants will be screened for MDRO on admission to the John Farman Intensive Care Unit. All specimens will be assigned a unique anonymised identification number prior to transfer to the research laboratory the Department of Medicine for processing. Participants will be screened for MDRO on discharge from ICU, and weekly during their ICU admission if the duration of admission is 7 days or longer.
Intervention type	Other
Primary outcome measure	Measured using patient records during the study period: 1. Number of patients colonised with multidrug-resistant organisms 2. Number of patients with clinical evidence of infection with multidrug-resistant organisms 3. Number of transmission events of multidrug-resistant organisms
Secondary outcome measures	Measured using patient records during the study period: 1. Risk factors for colonisation / infection with multidrug-resistant organisms 2. Outcome of patients colonised / infected with multidrug-resistant organisms 3. Cost-consequences of whole-genome sequencing versus standard epidemiological investigation / typing for surveillance and investigation of suspected outbreaks and the management of confirmed outbreaks
Overall study start date	01/01/2016
Completion date	30/06/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	All patients admitted to ICU in a 6 month period (N=400)
Key inclusion criteria	1. Aged 18 years old or older 2. Male or female 3. Admitted to the John Farman Intensive Care Unit during the study period
Key exclusion criteria	Does not fulfil study inclusion criteria
Date of first enrolment	20/06/2016
Date of final enrolment	20/12/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Cambridge Biomedical Campus

Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust
Hospital/treatment centre

R&D Department
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Phone	+44 (0)1223 348490
Email	research@addenbrookes.nhs.uk
Website	http://www.cuh.org.uk/
"ROR"	https://ror.org/04v54gj93

University of Cambridge
University/education

School of Clinical Medicine
Box 111 Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Phone	+44 (0)1223 766362
Email	jo.deckers@admin.cam.ac.uk
Website	http://www.cam.ac.uk/
"ROR"	https://ror.org/013meh722

Funders

Funder type

Research organisation

Academy of Medical Sciences
Private sector organisation / Other non-profit organizations

Alternative name(s): The Academy of Medical Sciences
Location: United Kingdom

The Health Foundation

No information available

National Institutes of Health Research Cambridge Biomedical Research Centre

No information available

Results and Publications

Intention to publish date	31/12/2020
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version v2.0		06/03/2020	No	No
HRA research summary			28/06/2023	No	No

Additional files

ISRCTN13493757_PROTOCOL_v2.0_Jan2016.pdf: Uploaded 06/03/2020

Editorial Notes

06/03/2020: Uploaded protocol version 2.0 January 2016 (not peer reviewed).
18/02/2020: Trial’s existence confirmed by NHS Health Research Authority, East of England - Cambridge Central Research Ethics Committee.