Surveillance of healthcare associated pathogens in hospital/community settings

ISRCTN	ISRCTN59966745
DOI	https://doi.org/10.1186/ISRCTN59966745
Secondary identifying numbers	NH001

Submission date: 30/07/2013
Registration date: 10/09/2013
Last edited: 06/02/2017

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
Healthcare-associated infections are an important problem in hospitals and much research has been carried out on the bacteria that cause healthcare-associated infections (e.g. methicillin-resistant Staphylococcus aureus (MRSA) and Clostridium difficile) and the measures to control them. More recently, organisms that are resistant to many antibiotics, such as multi-drug resistant Gram-negative bacilli (MDR GNB) and vancomcyin-resistant enterococci (VRE), have become a problem in hospitals and are now a focus of research. In contrast, there has been little or no research done about healthcare-associated infections in community settings such as nursing homes. However, many people living in nursing homes are at risk of infection with these bacteria because of their underlying medical condition, antibiotic treatment, and contact with hospital either as an outpatient or an inpatient. The aim of this study is to look at the frequency of these organisms at Addenbrookes hospital and in the nursing home. This involves collection of samples for laboratory testing in order to identify the organisms that cause healthcare-associated infections (e.g. MRSA, C. difficile, MDR GNB and VRE). Genetic fingerprinting (whole genome sequencing) of the bacteria is also performed in order to understand the movement of organisms between patients and between the hospital and community setting.

Who can participate?
All patients admitted to Addenbrookes hospital and residents in a nursing home in Cambridge during the study period.

What does the study involve?
In the hospital, samples for testing are collected when indicated as part of routine clinical care. In the nursing home, samples are taken up to once a week for the duration of the study. The samples include swabs from the patient's nose, throat, groin, and any open wounds or ulcers. Samples of urine are also collected (if there is a urinary catheter) and stool (faeces). If a stool sample is not available then a rectal (bottom) swab is collected. Some clinical information is also collected from medical records. There are no study-specific interventions and all patients receive routine clinical care.

What are the possible benefits and risks of participating?
There are no direct benefits to the participant for taking part in the study. However, the information obtained from the study may help future patients and reduce the risk of healthcare-associated infections. There are no risks to the participant from taking part in the study. Having the samples taken may be mildly uncomfortable but does not hurt.

Where is the study run from?
The study is being run by the Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge (UK).

When is the study starting and how long is it expected to run for?
October 2013 to October 2014

Who is funding the study?
The Wellcome Trust and the Department of Health (UK)

Who is the main contact?
Professor Sharon Peacock
sjp97@medschl.cam.ac.uk

Contact information

Prof Sharon Peacock
Scientific

University of Cambridge
Department of Medicine
Box 157
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

ORCID ID	0000-0002-1718-2782
Phone	+44 (0)1223 336 867
Email	sjp97@medschl.cam.ac.uk

Study information

Study design	Prospective 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 to request a patient information sheet
Scientific title	A prospective surveillance study to define rates of carriage, transmission and infection by healthcare-associated pathogens in adjacent hospital and community settings
Study hypothesis	To determine the rates of carriage, transmission, and infection by specified healthcare-associated pathogens (MRSA, C. difficile, MDR GNB and VRE) in hospital and nursing home settings, using a combination of epidemiological investigation and bacterial whole genome sequencing.
Ethics approval(s)	NRES committee: London Queen Square, 03/02/2014, ref: 13/LO/1278
Condition	Healthcare associated pathogens e.g. Methicillin resistant Staphylococcus aureus (MRSA), Clostridium difficile, multidrug resistant Gram negative bacteria (MDR GNB), vancomycin resistant enterococci (VRE)
Intervention	A study of patients admitted to Addenbrooke's hospital and a nursing home during the one year study period. The frequency of carriage and infection with healthcare-associated bacteria will be determined by microbiological testing. Transmission of healthcare-associated bacteria will be determined using bacterial whole-genome sequencing.
Intervention type	Other
Primary outcome measure	1. Rate of carriage of MRSA, C. difficile, MDR GNB and VRE over time in hospital and nursing home populations 2. Rate of transmission of MRSA, C. difficile, MDR GNB and VRE over time within and between hospital and nursing home populations 3. Incidence of healthcare-associated infections by MRSA, C. difficile, MDR GNB and VRE over time in hospital and nursing home populations
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/10/2013
Overall study end date	01/10/2014

Eligibility

Participant type(s)	Patient
Age group	All
Sex	Both
Target number of participants	65,250
Participant inclusion criteria	1. Inpatient at Addenbrookes hospital OR nursing home resident 2. Age 1 day to no upper age limit 3. Male or female 4. Microbiological testing for MRSA, C. difficile, MDR GNB, or VRE carriage or infection
Participant exclusion criteria	The participant may not enter the study if they do not fulfil the inclusion criteria
Recruitment start date	07/03/2014
Recruitment end date	19/09/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Cambridge

Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Dr Stephen Kelleher
R&D Department
Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Phone	+44 (0)1223 217418
Email	stephen.kelleher@addenbrookes.nhs.uk
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Charity

The study is joint funded by the Wellcome Trust (reference: WT098600) and the Department of Health (reference: HICF-T5-342) through a Health Innovation Challenge Fund Grant

No information available

Results and Publications

Intention to publish date	06/08/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	One further paper is currently under review.
IPD sharing plan	The genome sequence data for the bacterial isolates publicly available after submitted to European Nucleotide Archive. Details provided in publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/01/2016		Yes	No
Results article	results	01/03/2016		Yes	No
Results article	results	01/08/2016		Yes	No
Results article	results	03/10/2016		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

06/02/2017: Publication references added.