Condition category
Infections and Infestations
Date applied
13/02/2020
Date assigned
20/02/2020
Last edited
06/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

http://www.cuh.org.uk/

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

http://www.cam.ac.uk/

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

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.