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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 180415 |
| Protocol serial number | CUH R&D ref: A093680, IRAS 180415 |
| Sponsors | Cambridge University Hospitals NHS Foundation Trust, University of Cambridge |
| Funders | Academy of Medical Sciences, The Health Foundation, National Institutes of Health Research Cambridge Biomedical Research Centre |
- 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
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
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 |
| et317@cam.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant 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(s) |
Measured using patient records during the study period: |
| Key secondary outcome measure(s) |
Measured using patient records during the study period: |
| Completion date | 30/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| 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? |
|---|---|---|---|---|---|
| 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 v2.0 | 06/03/2020 | 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.
