Condition category
Infections and Infestations
Date applied
24/01/2014
Date assigned
06/02/2014
Last edited
06/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
About 30 % of all healthcare-associated infections are caused by certain bacteria called Enterobacteriacae. A group of Enterobacteriaceae which is resistant to a number of antibiotics is called ‘extended-spectrum beta-lactamase (ESBL) producers’. The rapidly increasing prevalence of ESBL-producers in Europe is a cause for concern.
‘To isolate or not to isolate’ patients with ESBL-producing Enterobacteriacae is currently one of the most controversial questions in the field of infection control (IC).
Isolation measures may be associated with increased costs and side effects for the individual patient such as depression and reduced contact with attending physicians.
Standard precautions (SP) may be as effective for limiting the spread of ESBL, if the hand hygiene procedures are followed.
Adding isolation measures for the rapidly increasing number of patients colonized with ESBL should be more evidence based.
The aim of the study is to determine the additional effects of isolation measures compared to SP on the frequency of getting infected by ESBL-producing Enterobacteriacae.

Who can participate?
Hospitals with adult medical and surgical wards where ESBL-producing Enterobacteriacae infection rates are high.

What does the study involve?
The study involves two different infection control strategies (standard precautions [SP] and contact isolation [CI]). All participating hospital wards will adopt both strategies for a period of 12 months each with a break of one month between the two study periods, with the order that they adopt the two strategies being randomly allocated. During the SP strategy for all patients hand hygiene will be consistent with the World Health Organization’s (WHO’s) ‘Five Moments’ recommendations. Clean gloves and gowns/aprons will be used for all interactions that involve potentially infectious procedures. This strategy represents the current standard of care and all patients will be subjected to this infection control strategy on wards in the SP phase of the trial. During the CI strategy all patients who are known to be infected with ESBL before admission will be cared for using CI, preferably in a single room or in a shared room with patients who are infected with the same organism. If isolation in a single room or a shared room with patients infected with the same organism is impossible, gloves and gowns/aprons will be used for all interactions with the patient or the patient’s environment in a shared room. Hand hygiene will be performed according to WHO’s ‘Five Moments’.

What are the possible benefits and risks of participating?
The overall benefit of the study will be evidence for hospitals across Europe to use (or not to use) isolation measures for patients colonized with ESBL-producing Enterobacteriaceae. Participating wards will have the benefit of an intensive supervision by IC professionals in order to have good quality in care. The study will involve no more than minimal risk of harm to patients.

Where is the study run from?
Charité -Universitätsmedizin Berlin (Berlin, Germany), Hospital Ramón y Cajal (Madrid, Spain), Hopitaux Universitaires de Geneve (Geneva, Switzerland), Universitair Medisch Centrum Utrecht (Utrecht, The Netherlands).

When is the study starting and how long is it expected to run for?
The study started in January 2014 and is expected to run until July 2016.

Who is funding the study?
The study is funded by the European Commission, DG Research.


Who is the main contact?
Professor Petra Gastmeier (Principal Investigator)
Charité – Universitätsmedizin Berlin, Germany

Trial website

http://www.r-gnosis.eu

Contact information

Type

Scientific

Primary contact

Prof Petra Gastmeier

ORCID ID

Contact details

Hindenburgdamm 27
Berlin
12203
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FP7-HEALTH-2011-SINGLE STAGE - N°282512

Study information

Scientific title

Resistance of Gram-Negative Organisms: Studying Intervention Strategies: Work Package 5

Acronym

R-GNOSIS WP5

Study hypothesis

If all ESBL-carriers are identified, contact isolation will not reduce ESBL incidence densities of ESBL-acquisition among patients in medical and surgical wards when compared to standard precautions.

Ethics approval

1. Charité University Medicine Berlin, Germany, 25/04/2013, ref.: EA1/323/12
2. University Medical Center Utrecht, Netherlands, 05/09/2013, ref.:WAG/om/13/069083
3. University of Geneva, Switzerland, 01/10/2013, ref.:CER 13-187
4. Hospital Ramon y Cajal-SERMAS, Spain, 21/10/2013

Study design

Cluster-randomized controlled study of two infection control strategies with cross-over design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Nosocomial transmission of ESBL-producing Enterobacteriaceae

Intervention

Two different interventions:
1. Contact Isolation (CI) according to Centers for Disease Control and Prevention (CDC)/Healthcare Infection Control Practices Advisory Committee (HICPAC). Management of multidrug-resistant organisms in healthcare settings, 2006.
2. Standard Precautions (SP): Indications and technique for hand hygiene consistent with those recommended by the WHO’s 'Five Moments'. Clean gloves and gowns/aprons for all interactions that involve potentially infectious procedures.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

ESBL acquisition rate per 1,000 patient days. This will be measured at the end of each intervention period. Isolates will be analysed microbiologically and acquisition of ESBL-carriage will be defined as recovery of ESBL isolates from clinical and/or screening specimens >3 days after hospital admission (admission day = day 1) from patients with negative admission screening results.

Secondary outcome measures

1. New events of nosocomial ESBL infections: New events of nosocomial ESBL infections will be obtained by a continuous surveillance on the participating wards according to the Centers for Disease Control and Prevention (CDC) definitions for HAI.
2. Episodes of hand hygiene and use of gloves and gowns/aprons by healthcare workers during patient care: will be assessed in all participating wards for both intervention periods by novel electronic counting devices integrated into alcoholic handrub dispensers as well as by direct observations performed by trained monitors using a standardized observation procedure in months 3, 9, 16 and 22.
3. The antibiotic use of the wards will be collected monthly, preferably in defined daily dose (DDD) per 1000 patient-days.
4. Alcohol-based handrub consumption: Data of total handrub consumption on the ward will be obtained by the end of each intervention period.

Overall trial start date

06/01/2014

Overall trial end date

31/07/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Peripheral medical and surgical wards

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20 wards in Europe (Germany, The Netherlands, Spain and Switzerland) with approximately 40,000 patients

Participant exclusion criteria

Wards that meet any of the following criteria are excluded from the study:
1. Haematological wards
2. Oncologic wards
3. Transplant wards
4. Paediatric wards

Recruitment start date

06/01/2014

Recruitment end date

31/07/2016

Locations

Countries of recruitment

Germany, Netherlands, Spain, Switzerland

Trial participating centre

Hindenburgdamm 27
Berlin
12203
Germany

Sponsor information

Organisation

University Medicine Berlin (Germany)

Sponsor details

Institute of Hygiene
Charité
Hindenburgdamm 27
Berlin
12203
Germany

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

European Commission, DG Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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