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 Organizations (WHOs) 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 patients environment in a shared room. Hand hygiene will be performed according to WHOs 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
FP7-HEALTH-2011-SINGLE STAGE - N°282512
Resistance of Gram-Negative Organisms: Studying Intervention Strategies: Work Package 5
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.
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
Cluster-randomized controlled study of two infection control strategies with cross-over design
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Nosocomial transmission of ESBL-producing Enterobacteriaceae
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 WHOs 'Five Moments'. Clean gloves and gowns/aprons for all interactions that involve potentially infectious procedures.
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
Overall trial end date
Participant inclusion criteria
Peripheral medical and surgical wards
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
Recruitment end date
Countries of recruitment
Germany, Netherlands, Spain, Switzerland
Trial participating centre
European Commission, DG Research
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