Methicillin-Resistant Staphylococcus AureusNCT01138462
Control of MRSA in Nursing Homes: Decolonization vs Standard Precautions
A study testing intervention in people with Methicillin-Resistant Staphylococcus Aureus, run by University of Lausanne Hospitals.
Trial summary
The purpose of this study is to determine the better approach between the currently procedure (i.e. standards precautions) and a reinforced strategy to control MRSA transmission in the institutionalized population of nursing homes in Canton of Vaud, Switzerland. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Methicillin-Resistant Staphylococcus Aureus
- What is being tested?
- intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all nursing homes of canton Vaud, Switzerland, that give the consent of participation
Who cannot join
- refusal to participate
- Inclusion criteria for decolonisation in intervention nursing homes:
- all MRSA positive residents living in a Nursing Home included in the intervention group
- residents that refuse to be screened or refused the decolonisation
- life expectancy shorter of 7 days
- known intolerance of disinfectant/ topical antibiotics used in the protocol
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- active MRSA infection
- asymptomatic MRSA bacteriuria
- stage IV wound (according to National Pressure Ulcer Advisory Panel)
About this study
Official title: Universal Screening and Decolonization vs Standard Precautions for Control of Methicillin-resistant Staphylococcus Aureus (MRSA) in Nursing Homes: a Cluster, Randomised Controlled Study.
The purpose of this study is to determine the better approach between the currently procedure (i.e. standards precautions) and a reinforced strategy to control MRSA transmission in the institutionalized population of nursing homes in Canton of Vaud, Switzerland.
Read the detailed description
MRSA carriage among nursing homes residents of Canton Vaud, Switzerland, is increasing, despite use of standard precautions. Recommendation to prevent MRSA transmission in long term care facilities are lacking. We aim to reinforce the current infection control strategy by general MRSA screening of institutionalised residents and decolonisation of MRSA carriers. Because the uncertainties in the impact of this reinforced strategy, we aim to compare this action to the policy actually applied.
- Being tested
- intervention
- Keywords
- Methicillin-Resistant Staphylococcus aureus, Decolonisation, Nursing homes, Infection Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventionOther
Also called topical MRSA decolonisation and environmental disinfection
5 days topical decolonisation including nasal mupirocin tid, chlorhexidine mouth wash tid, chlorhexidine body wash once daily.
Daily direct resident's environmental disinfection during decolonisation.
| Study group | Role | What they receive |
|---|---|---|
| Standard Precautions | No intervention | control arm, standards precautions for all residents living in the nursing home of control arm, including MRSA carriers |
| Intervention | Other | Intervention arm, standards precautions for all residents living in nursing homes of intervention arm, and topical decolonization for MRSA carriers, including environmental disinfection Receives: Other: intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the change in prevalence of MRSA carriage among residents of each Nursing homes group at the end of the one study year
in each control and intervention nursing home: MRSA screening of all residents of nursing homes of Canton Vaud, at baseline and 1 year later, in order to compare MRSA prevalence changes at nursing homes levels
Measured: 1 year
Secondary outcomes (1)
To determine the effectiveness of the reinforced strategy to prevent MRSA infection, compared to the standard strategy
In a subpopulation of all nursing homes residents (10% of the whole population), recording of all microbiologically documented MRSA infection, according to nosocomial infection definitions of the Center of Diseases Control (CDC) of Atlanta.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- Study completionDec 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 Methicillin-Resistant Staphylococcus AureusStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bellini Cristina, University of Lausanne Hospitals
- Investigators
- Giorgio Zanetti, MD, Study director, University Hospital of Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138462
- Sponsor's protocol ID
- Protocole 96/10
- Status last verified
- Mar 2020
- First submitted
- 4 Jun 2010
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Bellini C, Petignat C, Masserey E, Bula C, Burnand B, Rousson V, Blanc DS, Zanetti G. Universal screening and decolonization for control of MRSA in nursing homes: a cluster randomized controlled study. Infect Control Hosp Epidemiol. 2015 Apr;36(4):401-8. doi: 10.1017/ice.2014.74.
PubMed 25782894
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Universal Screening and Decolonization vs Standard Precautions for Control of Methicillin-resistant Staphylococcus Aureus (MRSA) in Nursing Homes: a Cluster, Randomised Controlled Study.
- ClinicalTrials.gov ID
- NCT01138462
- Acronym / sponsor ID
- Protocole 96/10
- Keywords
- Methicillin-Resistant Staphylococcus aureus, Decolonisation, Nursing homes, Infection Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Jun 2010 (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 purpose of this study is to determine the better approach between the currently procedure (i.e. standards precautions) and a reinforced strategy to control MRSA transmission in the institutionalized population of nursing homes in Canton of Vaud, Switzerland.
Detailed description
MRSA carriage among nursing homes residents of Canton Vaud, Switzerland, is increasing, despite use of standard precautions. Recommendation to prevent MRSA transmission in long term care facilities are lacking. We aim to reinforce the current infection control strategy by general MRSA screening of institutionalised residents and decolonisation of MRSA carriers. Because the uncertainties in the impact of this reinforced strategy, we aim to compare this action to the policy actually applied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Precautions | No intervention | –control arm, standards precautions for all residents living in the nursing home of control arm, including MRSA carriers |
| Intervention | Other | Other: interventionIntervention arm, standards precautions for all residents living in nursing homes of intervention arm, and topical decolonization for MRSA carriers, including environmental disinfection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all nursing homes of canton Vaud, Switzerland, that give the consent of participation
Key exclusion criteria (9 listed)
- refusal to participate
- all MRSA positive residents living in a Nursing Home included in the intervention group
- residents that refuse to be screened or refused the decolonisation
- life expectancy shorter of 7 days
- known intolerance of disinfectant/ topical antibiotics used in the protocol
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 |
|---|---|---|
| interventionAlso: topical MRSA decolonisation and environmental disinfection5 days topical decolonisation including nasal mupirocin tid, chlorhexidine mouth wash tid, chlorhexidine body wash once daily. Daily direct resident's environmental disinfection during decolonisation. | Other | Intervention |
Primary outcome
To determine the change in prevalence of MRSA carriage among residents of each Nursing homes group at the end of the one study year
Time frame: 1 year
in each control and intervention nursing home: MRSA screening of all residents of nursing homes of Canton Vaud, at baseline and 1 year later, in order to compare MRSA prevalence changes at nursing homes levels
1 secondary outcome
To determine the effectiveness of the reinforced strategy to prevent MRSA infection, compared to the standard strategy
Time frame: 1 year
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 30 Mar 2020.
- Background: PubMed 25782894Bellini C, Petignat C, Masserey E, Bula C, Burnand B, Rousson V, Blanc DS, Zanetti G. Universal screening and decolonization for control of MRSA in nursing homes: a cluster randomized controlled study. Infect Control Hosp Epidemiol. 2015 Apr;36(4):401-8. doi: 10.1017/ice.2014.74.
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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.
Giorgio Zanetti, MD study director
University Hospital of Lausanne, Switzerland
Questions about this trial
What is this clinical trial studying?
A study testing intervention in people with Methicillin-Resistant Staphylococcus Aureus, run by University of Lausanne Hospitals.
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 9 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 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
To determine the change in prevalence of MRSA carriage among residents of each Nursing homes group at the end of the one study year (time frame: 1 year). 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 NCT01138462, 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 30 Mar 2020.