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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. Identifier: NCT00976638
Recruitment Status : Completed
First Posted : September 14, 2009
Last Update Posted : August 6, 2012
Information provided by (Responsible Party):
MJM Bonten, UMC Utrecht

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14318 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

  2. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • colonization with either MRSA, VRE or ESBL is endemic
  • at least one dedicated infection control physician
  • ability to obtain, store and analyze surveillance cultures
  • at least 8 ICU beds; all of which have possibility for mechanical ventilation
  • ability to collect the data required for analysis
  • written approval of the institution's IRB
  • signed protocol signature page

Exclusion Criteria:

  • burn units
  • cardiothoracic units
  • pediatric and neonatal ICUs
  • ICU is currently using rapid diagnostic testing in their screening program for AMRB
  • ICU is planning to enroll subjects in studies testing investigational agents for the purpose of eradicating or preventing colonization with MRSA, VRE or ESBL or devices or practice management strategies that have colonization and/or infection with AMRB as an outcome
  • using SOD/ SDD or any topical antimicrobial therapy
  • using chlorhexidine body washings

Information from the National Library of Medicine

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 identifier (NCT number): NCT00976638

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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
Sponsors and Collaborators
UMC Utrecht
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Principal Investigator: Marc Bonten, Prof, MD UMC Utrecht
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: MJM Bonten, MD, PhD, UMC Utrecht Identifier: NCT00976638    
Other Study ID Numbers: LSHP-CT-2007-037941
First Posted: September 14, 2009    Key Record Dates
Last Update Posted: August 6, 2012
Last Verified: August 2012
Keywords provided by MJM Bonten, UMC Utrecht:
Antimicrobial Resistant Bacteria
Hospital acquired infections
Intensive Care
Additional relevant MeSH terms:
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Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes