Hospital Acquired Infections Clinical Trial
Official title:
Mastering Hospital Antibiotic Resistance, a Cluster Randomized Intervention Study in Intensive Care Units Throughout Europe (Work Package 3)
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:
1. Advances in behavioral sciences and research about (hand) hygiene compliance have
allowed a better understanding of barriers to increase compliance with (hand) hygiene
practices within healthcare institutions;
2. Recent investigations have identified new rapid tests, both chromogenic media and
molecular based tests, which may help identifying previously unknown carriage of AMRB
at the time of admission; and
3. Currently practiced procedures, such as regular surveillance of all patients and daily
cleansing of ICU patients with Chlorhexidine, have not been evaluated properly for
their effectiveness.
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:
- Evaluate the impact of interventions on ICU-acquired bacteremia rates with MRSA, VRE or
ESBL.
- Evaluate the impact of the HIP intervention on frequency and quality of hand hygiene,
the application of standard precautions and the use of contact precautions during
patient care.
- Evaluate the effect of the three strategies on other patient outcomes, including length
of stay and in hospital mortality.
- Evaluate the overall antibiotic use and effectiveness of empirical treatment of
ICU-acquired bacteremia.
- Evaluate the effect of the three strategies on the incidence density of new
acquisitions with MRSA, VRE and ESBL individually.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
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