Hospital Acquired InfectionsMOSAR-ICUNCT00976638
Clinical Trial to Reduce Antibiotic Resistance in European Intensive Cares
A study testing Chromogenic surveillance and Molecular surveillance in people with Hospital Acquired Infections, run by UMC Utrecht at 13 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Acquired Infections
- What is being tested?
- Chromogenic surveillance and Molecular surveillance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,318 participants
- Where
- 13 sitesin 8 countries
- Study dates
- Jun 2008to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 8 countries.
13 sites in 8 countries
France3 sites
Hopital Henri Mondor
Créteil, 94000
Raymond Poincare Hospital
Garches, F-92380
Hopital Paris Saint Joseph
Paris, 75674
Greece2 sites
Laikon General Hospital
Athens, 11527
University General Hospital Attikon
Athens, 12462
Portugal2 sites
Hospital Geral de Sto Antonio
Porto, 4260-363
Tras-os-Montes e Alto Douro
Vila Real, 5000-508
Slovenia2 sites
University Clinic of Respiratory and Allergic Diseases
Golnik, 4204
University Medical Center Ljubljana
Ljubljana, SI 1000
About this study
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.
Read the detailed description
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:
- 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;
- 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
- 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.
- Conditions
- Hospital Acquired Infections
- Being tested
- Chromogenic surveillance, Molecular surveillance
- Keywords
- Antimicrobial Resistant Bacteria, Hospital acquired infections, Colonization, Bacteremia, MRSA, VRE, ESBL, Intensive Care, ICU
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromogenic surveillanceOther
Also called chromogenic screening
All admitted patients are screened on admission for MRSA and VRE by chromogenic agar and isolated when positive
Molecular surveillanceOther
Also called molecular screening
All patients are screened for MRSA and VRE by PCR; and for ESBL by chromogenic agar on admission. Positive patients are isolated
| Study group | Role | What they receive |
|---|---|---|
| Chromogenic Arm | Active comparator | Active surveillance of colonization with MRSA or VRE by chromogenic agar with isolation of positive patients. Receives: 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 Receives: Other: Molecular surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During ICU stay
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startJun 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospital Acquired InfectionsStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14,318 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MJM Bonten, UMC Utrecht
- Investigators
- Marc Bonten, Prof, MD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976638
- Sponsor's protocol ID
- LSHP-CT-2007-037941
- Other IDs
- WP3
- Acronym
- MOSAR-ICU
- Status last verified
- Aug 2012
- First submitted
- 11 Sep 2009
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24161233
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastering Hospital Antibiotic Resistance, a Cluster Randomized Intervention Study in Intensive Care Units Throughout Europe (Work Package 3)
- ClinicalTrials.gov ID
- NCT00976638
- Acronym / sponsor ID
- MOSAR-ICU / LSHP-CT-2007-037941
- Conditions
- Hospital Acquired Infections
- Keywords
- Antimicrobial Resistant Bacteria, Hospital acquired infections, Colonization, Bacteremia, MRSA, VRE, ESBL, Intensive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,318 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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;
- 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
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chromogenic Arm | Active comparator | Other: Chromogenic surveillanceActive surveillance of colonization with MRSA or VRE by chromogenic agar with isolation of positive patients. |
| Molecular Arm | Active comparator | Other: Molecular surveillanceActive surveillance of colonization with MRSA and VRE by PCR; and of ESBL by chromogenic agar with isolation of positive patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chromogenic surveillanceAlso: chromogenic screeningAll admitted patients are screened on admission for MRSA and VRE by chromogenic agar and isolated when positive | Other | Chromogenic Arm |
| Molecular surveillanceAlso: molecular screeningAll patients are screened for MRSA and VRE by PCR; and for ESBL by chromogenic agar on admission. Positive patients are isolated | Other | Molecular Arm |
Primary outcome
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.
3 secondary outcomes
Incidence density of new acquisitions with MRSA, VRE and ESBL individually.
Time frame: Acquired during ICU stay (median LOS 14 days)
ICU-acquired bacteremia rates with MRSA,VRE or ESBL.
Time frame: Acquired during ICU stay (median LOS 14 days)
28 day-mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2012.
- Derived from this study: PubMed 24161233Derde 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Bonten, Prof, MD principal investigator
UMC Utrecht
13 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chromogenic surveillance and Molecular surveillance in people with Hospital Acquired Infections, run by UMC Utrecht at 13 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Greece, Portugal, Slovenia, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colonization with MRSA, VRE and ESBL (time frame: On admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00976638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2012.