Clinical Trial to Reduce Antibiotic Resistance in European Intensive Cares (MOSAR-ICU)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00976638|
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : August 6, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Hospital Acquired Infections||Other: Chromogenic surveillance Other: Molecular surveillance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14318 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mastering Hospital Antibiotic Resistance, a Cluster Randomized Intervention Study in Intensive Care Units Throughout Europe (Work Package 3)|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Active Comparator: Chromogenic Arm
Active surveillance of colonization with MRSA or VRE by chromogenic agar with isolation of positive patients.
Other: Chromogenic surveillance
All admitted patients are screened on admission for MRSA and VRE by chromogenic agar and isolated when positive
Other Name: chromogenic screening
Active Comparator: Molecular Arm
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 patients are screened for MRSA and VRE by PCR; and for ESBL by chromogenic agar on admission. Positive patients are isolated
Other Name: molecular screening
- Colonization with MRSA, VRE and ESBL [ Time Frame: On admission ]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.
- Colonization with MRSA, VRE and ESBL [ Time Frame: During ICU stay ]
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.
- Incidence density of new acquisitions with MRSA, VRE and ESBL individually. [ Time Frame: Acquired during ICU stay (median LOS 14 days) ]
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.
- ICU-acquired bacteremia rates with MRSA,VRE or ESBL. [ Time Frame: Acquired during ICU stay (median LOS 14 days) ]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.
- 28 day-mortality [ Time Frame: 28 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976638
|Hopital Henri Mondor|
|Creteil, France, 94000|
|Raymond Poincare Hospital|
|Garches, France, F-92380|
|Hopital Paris Saint Joseph|
|Paris, France, 75674|
|Laikon General Hospital|
|Athens, Greece, 11527|
|University General Hospital Attikon|
|Athens, Greece, 12462|
|San Camillo Forlanini Hospital|
|Rome, Italy, 00152|
|Paul Stradins University Hospital|
|Riga, Latvia, LV-1008|
|Centre Hospitalier de Luxembourg|
|Luxembourg, Luxembourg, L-1210|
|Hospital Geral de Sto Antonio|
|Porto, Portugal, 4260-363|
|Tras-os-Montes e Alto Douro|
|Vila Real, Portugal, 5000-508|
|University Clinic of Respiratory and Allergic Diseases|
|Golnik, Slovenia, 4204|
|University Medical Center Ljubljana|
|Ljubljana, Slovenia, SI 1000|
|Hospital Clinic Y Provencal|
|Barcelona, Spain, 8025|
|Principal Investigator:||Marc Bonten, Prof, MD||UMC Utrecht|