Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Estee Torok
ORCID ID
http://orcid.org/0000-0001-9098-8590
Contact details
University of Cambridge
Department of Medicine
Box 157
Addenbrooke's Hospital
Hills Road
Cambridge
CB1 7TP
United Kingdom
01223 336845
et317@cam.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CUH R&D ref: A093680, IRAS 180415
Study information
Scientific title
Whole-genome sequencing to investigate colonisation and transmission of multidrug-resistant organisms in the adult intensive care unit at Addenbrooke’s Hospital
Acronym
ICU001
Study hypothesis
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
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
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/01/2016
Overall trial end date
30/06/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
All patients admitted to ICU in a 6 month period (N=400)
Participant exclusion criteria
Does not fulfil study inclusion criteria
Recruitment start date
20/06/2016
Recruitment end date
20/12/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cambridge Biomedical Campus
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospitals NHS Foundation Trust
Sponsor details
R&D Department
Cambridge University Hospitals NHS Foundation Trust
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 348490
research@addenbrookes.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Organisation
University of Cambridge
Sponsor details
School of Clinical Medicine
Box 111 Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 766362
jo.deckers@admin.cam.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Academy of Medical Sciences
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
The Health Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Institutes of Health Research Cambridge Biomedical Research Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.
Intention to publish date
31/12/2020
Participant level data
Other
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN13493757_PROTOCOL_v2.0_Jan2016.pdf Uploaded 06/03/2020