An interventional study of Chromogenic surveillance and Molecular surveillance in Hospital Acquired Infections, sponsored by UMC Utrecht. Completed at 13 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-06.
Sponsored by UMC Utrecht · Not applicable, Interventional, and Screening
Colonization of patients with Antimicrobial Resistant Bacteria (AMRB) like Methicillin Resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Enterococcus (VRE) and Extended-Spectrum Beta-Lactamases (ESBL) enterobacteriaceae leads to infections; and ultimately to adverse outcomes (eg prolonged hospital stay, death). This is an urgent problem in Europe, especially in Intensive Care Units (ICUs).
In this trial, colonization of patients with these AMRB will be assessed in the baseline period (6m). In phase 2 the effect of a Hygiene Improvement Program, including Chlorhexidine body washings and a Hand Hygiene training program, will be assessed (6m). In phase 3 units will be randomized to either Active Surveillance with Chromagar based tests or a Molecular based tests.
Study Hypothesis: the abovementioned interventions will reduce ICU-acquired colonization rates with MRSA, VRE and ESBL.
A cluster-randomized trial with a stepped wedge design will be conducted in adult ICU's throughout Europe
The MOSAR-ICU trial is motivated by three primary considerations:
In conclusion, evidence base derived recommendations from prospective studies regarding the costeffectiveness of different control strategies are lacking.
This study assess the impact of the three interventions on ICU acquired colonisation rates for AMRB(MRSA,VRE and ESBL).
Study design: Multi-center, cluster-randomised clinical trial.
Study population: Adult patients admitted to the ICU.
Intervention: The first phase of the study will be a 6-month baseline period to determine acquisition rates of AMRB during current standard practice in the individual participating centers (including currently performed surveillance strategies). The second phase will consist of a Hygiene Improvement Program to improve standard precautions and hand hygiene; and daily washing of all ICU patients with Chlorhexidine gluconate (HIP; 6 months). In both periods Contact Precautions (contact isolation) will be implemented for carriers of AMRB, as identified upon clinical cultures and following current practice of individual wards. In the third phase of the study (12 months) units will be randomized, and all interventions of phase 2 will be continued in all units. Half of the units will implement surveillance (admission and twice weekly cultures) of all admitted patients for carriage of MRSA and VRE using chromogenic agar. The other half will add molecular based rapid testing of ALL admission cultures for MRSA and VRE in addition to twice weekly screening of all patients with Chromagar based tests for MRSA, VRE and ESBL.
Main study endpoints: ICU-acquired colonization rates with MRSA, VRE and ESBL.
Primary Objective: To evaluate the impact of enhanced standard barrier precautions and rapid screening with targeted isolation of patients carrying AMRB on transmission of AMRB.
Secondary Objectives:
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 14,318 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →UMC Utrecht is the lead sponsor of 350 studies on the registry; 80 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active surveillance of colonization with MRSA or VRE by chromogenic agar with isolation of positive patients.
Other: Chromogenic surveillance
Active surveillance of colonization with MRSA and VRE by PCR; and of ESBL by chromogenic agar with isolation of positive patients
Other: Molecular surveillance
All admitted patients are screened on admission for MRSA and VRE by chromogenic agar and isolated when positive
Also known as: chromogenic screening
All patients are screened for MRSA and VRE by PCR; and for ESBL by chromogenic agar on admission. Positive patients are isolated
Also known as: molecular screening
Colonization with MRSA, VRE and ESBL
By taking surveillance swabs from nose, perineum and wounds (if present) on admission we will assess whether patients are colonized with MRSA, VRE and ESBL at the moment of ICU admission. Swabs will be processed on chromogenic agars.
Time frame: On admission
Colonization with MRSA, VRE and ESBL
By taking surveillance swabs twice weekly from nose, perineum and wounds (if present) we will assess whether patients become colonized with MRSA, VRE and ESBL during ICU stay. Swabs will be processed on chromogenic agars. Note: for patients admitted for longer than 21 days, surveillance is reduced to once weekly.
Time frame: During ICU stay
Incidence density of new acquisitions with MRSA, VRE and ESBL individually.
In phase 2, we implement a hygiene improvement program. We will assess if this program reduces the number of patients acquiring colonization with MRSA, VRE and ESBL. We will measure colonization as stated in the primary outcome measure. In phase 3, we will implement direct feedback of screening results, and isolation of colonized patients. Swabs will be processed either by chromogenic agar (a) or molecular tests (b). Thus, the effect of these interventions on incidence density of new acquisitions of MRSA, VRE or ESBL will be assessed.
Time frame: Acquired during ICU stay (median LOS 14 days)
ICU-acquired bacteremia rates with MRSA,VRE or ESBL.
We will collect data on all bacteremias occuring during ICU stay, after completion of the trial. We include all bacteremias with s aureus (MSSA and MRSA), e faecium/ e faecalis ("S" and "R") and enterobacteriaceae ("S" and "R"). Data will be collected from the microbiology labs.
Time frame: Acquired during ICU stay (median LOS 14 days)
28 day-mortality
We will collect length of stay, and disposition at d28 as well as disposition at discharge from the ICU. Data will be collected in the online CRF.
Time frame: 28 days
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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UMC Utrecht