Clinical Trial to Reduce Antibiotic Resistance in European Intensive Cares

NCT00976638 | Completed

• 2 other identifiers: LSHP-CT-2007-037941WP3
• Study Type: interventional
• Target: 14,318
• Locations: 8 countries
• Sites: 13

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.

Conditions

Hospital Acquired Infections

Keywords

Antimicrobial Resistant Bacteria; Hospital acquired infections; Colonization; Bacteremia; MRSA; VRE; ESBL; Intensive Care; ICU

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  During ICU stay

Secondary Outcomes (3)

• Incidence density of new acquisitions with MRSA, VRE and ESBL individually.

  Acquired during ICU stay (median LOS 14 days)

• ICU-acquired bacteremia rates with MRSA,VRE or ESBL.

  Acquired during ICU stay (median LOS 14 days)

• 28 day-mortality

  28 days

Study Arms (2)

Chromogenic Arm

ACTIVE COMPARATOR

Active surveillance of colonization with MRSA or VRE by chromogenic agar with isolation of positive patients.

Other: Chromogenic surveillance

Molecular Arm

ACTIVE COMPARATOR

Active surveillance of colonization with MRSA and VRE by PCR; and of ESBL by chromogenic agar with isolation of positive patients

Other: Molecular surveillance

Interventions

Chromogenic surveillance OTHER

All admitted patients are screened on admission for MRSA and VRE by chromogenic agar and isolated when positive

Also known as: chromogenic screening

Chromogenic Arm

Molecular surveillance OTHER

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

Molecular Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (13)

Hopital Henri Mondor

Créteil, 94000, France

Location

Raymond Poincare Hospital

Garches, F-92380, France

Location

Hopital Paris Saint Joseph

Paris, 75674, France

Location

Laikon General Hospital

Athens, 11527, Greece

Location

University General Hospital Attikon

Athens, 12462, Greece

Location

San Camillo Forlanini Hospital

Rome, 00152, Italy

Location

Paul Stradins University Hospital

Riga, LV-1008, Latvia

Location

Centre Hospitalier de Luxembourg

Luxembourg, L-1210, Luxembourg

Location

Hospital Geral de Sto Antonio

Porto, 4260-363, Portugal

Location

Tras-os-Montes e Alto Douro

Vila Real, 5000-508, Portugal

Location

University Clinic of Respiratory and Allergic Diseases

Golnik, 4204, Slovenia

Location

University Medical Center Ljubljana

Ljubljana, SI 1000, Slovenia

Location

Hospital Clinic Y Provencal

Barcelona, 8025, Spain

Location

Related Publications (1)

• Derde LPG, Cooper BS, Goossens H, Malhotra-Kumar S, Willems RJL, Gniadkowski M, Hryniewicz W, Empel J, Dautzenberg MJD, Annane D, Aragao I, Chalfine A, Dumpis U, Esteves F, Giamarellou H, Muzlovic I, Nardi G, Petrikkos GL, Tomic V, Marti AT, Stammet P, Brun-Buisson C, Bonten MJM; MOSAR WP3 Study Team. Interventions to reduce colonisation and transmission of antimicrobial-resistant bacteria in intensive care units: an interrupted time series study and cluster randomised trial. Lancet Infect Dis. 2014 Jan;14(1):31-39. doi: 10.1016/S1473-3099(13)70295-0. Epub 2013 Oct 23.

  PMID: 24161233 DERIVED

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Bonten, Prof, MD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: June 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 6, 2012

Record last verified: 2012-08

Locations

LU (1); IT (1); SL (2); GR (2); FR (3); ES (1); LA (1); PT (2)