Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

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.
We are therefore conducting a study to look at the frequency of these organisms at Addenbrooke’s hospital and in the nursing home. This will involve 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). We will also perform genetic fingerprinting (whole genome sequencing) of the bacteria to help us to better understand the movement of organisms between patients and between the hospital and community setting.

Who can participate?
The study will include all patients admitted to Addenbrooke’s hospital and residents in a nursing home in Cambridge during the study period.

What does the study involve?
In the hospital, samples for testing will be collected when indicated as part of routine clinical care. In the nursing home, samples will be taken up to once a week for the duration of the study. The samples will include swabs from the patient’s nose, throat, groin, and any open wounds or ulcers. We will also collect samples of urine (if there is a urinary catheter) and stool (faeces). If a stool sample is not available then we will collect a rectal (bottom) swab. We will also collect some clinical information from the medical records. There are no study-specific interventions and all patients will 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 that we obtain from the study may help future patients and enable us to 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 will 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?
The planned start date is October 2013 and the study will run for one year.

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

Who is the main contact?
Professor Sharon Peacock

Trial website

Contact information



Primary contact

Prof Sharon Peacock


Contact details

University of Cambridge
Department of Medicine
Box 157
Addenbrooke's Hospital
Hills Road
United Kingdom
01223 336 867

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

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

Submitted to National Research Ethics Service and Health Research Authority Confidentiality Advisory Group for approval - decisions awaited

Study design

Prospective observational cohort study

Primary study design


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Healthcare associated pathogens e.g. Methicillin resistant Staphylococcus aureus (MRSA), Clostridium difficile, multidrug resistant Gram negative bacteria (MDR GNB), vancomycin resistant enterococci (VRE)


A study of patients admitted to Addenbrooke's hospital and a nursing home during the one year study period.

We will determine the frequency of carriage and infection with healthcare-associated bacteria by microbiological testing. We will determine transmission of healthcare-associated bacteria using bacterial whole-genome sequencing.

Intervention type



Not Applicable

Drug names

Primary outcome measures

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 trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Inpatient at Addenbrooke’s 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 type


Age group




Target number of participants


Participant exclusion criteria

The participant may not enter the study if they do not fulfil the inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Cambridge
United Kingdom

Sponsor information


Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

c/o Dr Stephen Kelleher
R&D Department
Box 277
Addenbrooke's Hospital
Hills Road
United Kingdom
01223 217418

Sponsor type

Hospital/treatment centre



Funder type


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes