MRSA InfectionMOSAR-04NCT00685867
Two Strategies for Methicillin-resistant Staphylococcus Aureus (MRSA) Infection Prevention in Surgical Patients
A study testing Rapid molecular MRSA test and Hand hygiene promotion in people with MRSA Infection, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The study is a two-arm controlled multi-centre trial of two strategies to reduce nosocomial MRSA transmission and infection among surgical patients. Enrolment and primary analyses will be performed at the hospital level. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- MRSA Infection
- What is being tested?
- Rapid molecular MRSA test and Hand hygiene promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126,750 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2008to Dec 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Surgical patients with LOS>24h
Who cannot join
- Surgical patients with LOS<24h
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Interventional Study to Evaluate the Impact of Two Innovative Strategies in Preventing Nosocomial MRSA Infection in Surgical Patients
The study is a two-arm controlled multi-centre trial of two strategies to reduce nosocomial MRSA transmission and infection among surgical patients. Enrolment and primary analyses will be performed at the hospital level. A total of ten adult surgical departments with at least 3 surgical subspecialties each will participate in the study. Sites of the study are located in 9 countries (UK, France, Spain, Germany, Switzerland, Italy, Serbia, Greece and Israel).
The primary objective is to determine the effect of an early MRSA detection \& decolonization \& isolation strategy compared to an enhanced standard control strategy on healthcare-associated MRSA isolation rates among surgical patients at risk of MRSA carriage, who are hospitalized for at least 24 hours.
- Conditions
- MRSA Infection
- Being tested
- Rapid molecular MRSA test, Hand hygiene promotion
- Keywords
- Staphylococcus aureus, Resistance, Prevention
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid molecular MRSA testOther
PCR-based rapid screening for MRSA carriage
Hand hygiene promotionBehavioural
- Promotion and monitoring of hand hygiene, with special emphasis on alcohol-based hand rubs and feedback of hand hygiene compliance
- Standard precautions (e.g. use of gloves for contacts with wounds and body fluids)
- Isolation precautions according to the hospitals' capacity and strategy
- Additional basic infection control interventions (if necessary)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Rapid detection Receives: Other: Rapid molecular MRSA test |
| 2 | Other | Enhanced infection control Receives: Behavioral: Hand hygiene promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nosocomial MRSA isolation rate (expressed as the monthly rate of MRSA in clinical isolates divided by the number of susceptible patients per hundred)
Measured: Monthly
Secondary outcomes (1)
Nosocomial MRSA infection rate (= number of nosocomial MRSA infections per 100 admissions)
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2010
- Study completionDec 2010
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 MRSA InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126,750 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Stephen Harbarth, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685867
- Sponsor's protocol ID
- LSHP-CT-037940
- Other IDs
- LSHP-CT-037940
- Acronym
- MOSAR-04
- Status last verified
- Aug 2012
- First submitted
- 27 May 2008
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee AS, Cooper BS, Malhotra-Kumar S, Chalfine A, Daikos GL, Fankhauser C, Carevic B, Lemmen S, Martinez JA, Masuet-Aumatell C, Pan A, Phillips G, Rubinovitch B, Goossens H, Brun-Buisson C, Harbarth S; MOSAR WP4 Study Group. Comparison of strategies to reduce meticillin-resistant Staphylococcus aureus rates in surgical patients: a controlled multicentre intervention trial. BMJ Open. 2013 Sep 19;3(9):e003126. doi: 10.1136/bmjopen-2013-003126.
PubMed 24056477
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study to Evaluate the Impact of Two Innovative Strategies in Preventing Nosocomial MRSA Infection in Surgical Patients
- ClinicalTrials.gov ID
- NCT00685867
- Acronym / sponsor ID
- MOSAR-04 / LSHP-CT-037940
- Conditions
- MRSA Infection
- Keywords
- Staphylococcus aureus, Resistance, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126,750 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- May 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 May 2008 (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.
The study is a two-arm controlled multi-centre trial of two strategies to reduce nosocomial MRSA transmission and infection among surgical patients. Enrolment and primary analyses will be performed at the hospital level. A total of ten adult surgical departments with at least 3 surgical subspecialties each will participate in the study. Sites of the study are located in 9 countries (UK, France, Spain, Germany, Switzerland, Italy, Serbia, Greece and Israel).
The primary objective is to determine the effect of an early MRSA detection \& decolonization \& isolation strategy compared to an enhanced standard control strategy on healthcare-associated MRSA isolation rates among surgical patients at risk of MRSA carriage, who are hospitalized for at least 24 hours.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Rapid molecular MRSA testRapid detection |
| 2 | Other | Behavioral: Hand hygiene promotionEnhanced infection control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Surgical patients with LOS>24h
Key exclusion criteria (1 listed)
- Surgical patients with LOS<24h
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 |
|---|---|---|
| Rapid molecular MRSA testPCR-based rapid screening for MRSA carriage | Other | 1 |
| Hand hygiene promotion* Promotion and monitoring of hand hygiene, with special emphasis on alcohol-based hand rubs and feedback of hand hygiene compliance * Standard precautions (e.g. use of gloves for contacts with wounds and body fluids) * Isolation precautions according to the hospitals' capacity and strategy * Additional basic infection control interventions (if necessary) | Behavioural | 2 |
Primary outcome
Nosocomial MRSA isolation rate (expressed as the monthly rate of MRSA in clinical isolates divided by the number of susceptible patients per hundred)
Time frame: Monthly
1 secondary outcome
Nosocomial MRSA infection rate (= number of nosocomial MRSA infections per 100 admissions)
Time frame: Monthly
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 21 Aug 2012.
- Derived from this study: PubMed 24056477Lee AS, Cooper BS, Malhotra-Kumar S, Chalfine A, Daikos GL, Fankhauser C, Carevic B, Lemmen S, Martinez JA, Masuet-Aumatell C, Pan A, Phillips G, Rubinovitch B, Goossens H, Brun-Buisson C, Harbarth S; MOSAR WP4 Study Group. Comparison of strategies to reduce meticillin-resistant Staphylococcus aureus rates in surgical patients: a controlled multicentre intervention trial. BMJ Open. 2013 Sep 19;3(9):e003126. doi: 10.1136/bmjopen-2013-003126.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid molecular MRSA test and Hand hygiene promotion in people with MRSA Infection, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 inclusion and 1 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 21 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 1 site in Switzerland. 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?
Nosocomial MRSA isolation rate (expressed as the monthly rate of MRSA in clinical isolates divided by the number of susceptible patients per hundred) (time frame: Monthly). 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 NCT00685867, 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 21 Aug 2012.