Condition category
Infections and Infestations
Date applied
30/07/2013
Date assigned
10/09/2013
Last edited
06/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
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. The aim of this study is to look at the frequency of these organisms at Addenbrooke’s 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 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 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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sharon Peacock

ORCID ID

http://orcid.org/0000-0002-1718-2782

Contact details

University of Cambridge
Department of Medicine
Box 157
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 336 867
sjp97@medschl.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NH001

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

Acronym

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

NRES committee: London Queen Square, 03/02/2014, ref: 13/LO/1278

Study design

Prospective 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 to request a patient information sheet

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

Phase

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

01/10/2013

Overall trial end date

01/10/2014

Reason abandoned

Eligibility

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

Patient

Age group

All

Gender

Both

Target number of participants

65,250

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

United Kingdom

Trial participating centre

University of Cambridge
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

c/o Dr Stephen Kelleher
R&D Department
Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
+44 (0)1223 217418
stephen.kelleher@addenbrookes.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

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

Location

Results and Publications

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.

Intention to publish date

06/08/2017

Participant level data

Other

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27716432
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27312688
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26712266
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26759031

Publication citations

Additional files

Editorial Notes

06/02/2017: Publication references added.