Staph Aureus Methicillin Resistant ColonizationPhase 4NCT01717690
Study of 2% Chlorhexidine Gluconate-Impregnated Bath Cloths to Prevent MRSA Colonization in Complex Continuing Care
A Phase 4 study testing CHG antiseptic body cleanser in people with Staph Aureus Methicillin Resistant Colonization, run by Baycrest at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether daily bathing with 2% chlorhexidine gluconate-impregnated antiseptic cleanser (CHG) significantly reduces incidence of colonization of hospitalized patients with methicillin-resistant Staphylococcus aureus (MRSA). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Staph Aureus Methicillin Resistant Colonization
- What is being tested?
- CHG antiseptic body cleanser
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Sep 2014
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- MRSA-negative (at enrollment) inpatient of Complex Continuing Care program
Who cannot join
- MRSA-positive (at enrollment) inpatient of Complex Continuing Care program
Trial locations and contacts
1 site in 1 country.
Canada1 site
Baycrest Hospital, Complex Continuing Care program
Toronto, Ontario, M6A 2E1
About this study
Official title: Randomized Controlled Clinical Trial of 2% Chlorhexidine Gluconate-Impregnated Bath Cloths to Prevent MRSA Colonization on Complex Continuing Care Units of Baycrest Hospital
The purpose of this study is to determine whether daily bathing with 2% chlorhexidine gluconate-impregnated antiseptic cleanser (CHG) significantly reduces incidence of colonization of hospitalized patients with methicillin-resistant Staphylococcus aureus (MRSA).
Investigators postulate that daily bathing with CHG significantly reduces incidence of colonization of hospitalized patients with MRSA.
Read the detailed description
Bathing patients with 2% chlorhexidine gluconate-impregnated cloths (CHG) is an established practice at Baycrest. Our previous studies have demonstrated strong MRSA-preventive properties of CHG bathing practice - the rate of MRSA transmission on intervention units dropped from 4.99 to 0.88 cases per 1,000 patient days - an overall rate reduction of 82%.
Although CHG will continue to be used as part of an established clinical practice in our hospital, its impact on MRSA prevention merits further evaluation in complex continuing care (CCC) settings endemic for MRSA. Investigators propose a cluster-randomized, prospective, open-label, two-arm clinical trial (RCT) on three geographically separate, but otherwise comparable, CCC units - one intervention unit using CHG, and two control units using non-antiseptic cleanser. The RCT is expected to conclusively answer whether daily bathing with CHG significantly reduces incidence of MRSA colonization.
By cluster randomization investigators imply randomly assigning interventions to the three patient care units. Investigators propose randomization of the units as it is not feasible to randomly assign the individual participants to intervention vs control arms.
For a meaningful interpretation of the RCT findings, patient populations on the three floors will be compared at the beginning, during, and at the end of the study. The following variables will be used to compare patient populations:
- Colonization pressure (CP) is a measure of the MRSA reservoir on the unit. CP will be calculated at the onset of the RCT and then bi-weekly (Number of MRSA patient-days × 100 ÷ Total Number of Patient Days).
- Average Braden scale score (BSS) for patients on each unit is measured to predict a pressure ulcer risk. It is one of the measures of patient's clinical complexity. It is calculated by examining six patient criteria (sensory perception, skin moisture, physical activity, mobility, nutrition, friction and shear). BSS will be calculated at the onset of the RCT and then monthly.
- Average Case Mix Index (CMI) is a value reflecting the daily relative weight of resources used by an individual patient compared to a base resource level (the average resource use of the patient population). The CMI value is not a dollar amount; rather it is a relative value and an indirect marker of patient's clinical complexity. CMI will be calculated at the onset of the RCT and then quarterly.
Patient information will be de-identified for privacy reasons, before analysis of the study data - logistic regression, to compare the rates of MRSA incidence and time to MRSA conversion on intervention and control units.
- Being tested
- CHG antiseptic body cleanser
- Keywords
- MRSA, chlorhexidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHG antiseptic body cleanserDrug
Also called Chlorhexidine gluconate cloths, Drug Identification Number (Health Canada): 02245741
The intervention consists of daily bathing of all patients (MRSA-positive and MRSA-negative) on the intervention unit with CHG.
| Study group | Role | What they receive |
|---|---|---|
| CHG antiseptic body cleanser | Active comparator | One randomly selected intervention unit in Complex Continuing Care program where all patients (MRSA-positive and MRSA-negative) will be bathed daily with an antiseptic body cleanser (CHG).
Only MRSA-negative patients at enrollment will be included in the study analysis, and only their outcomes (MRSA status and time to conversion) will be analyzed.
Antiseptic body cleanser - 2% Chlorhexidine Gluconate in a non-alcohol and non-alkaline base, delivered to skin surface through the bath cloths impregnated with this antiseptic solution. Receives: Drug: CHG antiseptic body cleanser |
| Non-antiseptic body cleanser | No intervention | Two control units in Complex Continuing Care program where all patients (MRSA-positive and MRSA-negative) will be bathed daily with a non-antiseptic body cleanser (Comfort Bath ®). Only MRSA-negative patients at enrollment will be included in the study analysis, and only their outcomes (MRSA status and time to conversion) will be analyzed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of MRSA colonization
Primary outcome measure will be incidence of MRSA colonization measured through bi-weekly point-prevalence surveys on each of the three units. All new admissions and re-admissions to the units will also be screened. Protective properties of CHG bathing are expected to significantly reduce the incidence of MRSA transmission in the intervention arm, compared to control arms.
Measured: 12 months
Secondary outcomes (1)
Time to MRSA conversion
Secondary outcome measure will be time to MRSA conversion measured as the length of time it takes patients to convert from being MRSA-negative at enrollment to MRSA-positive at discharge or end of the study. Protective properties of CHG bathing are expected to significantly prolong conversion time.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startAug 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staph Aureus Methicillin Resistant ColonizationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baycrest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chingiz Amirov, Baycrest
- Investigators
- Chingiz Amirov, MPH, CIC, Principal investigator, Baycrest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717690
- Sponsor's protocol ID
- BCGC-CHG-2012
- Status last verified
- Feb 2015
- First submitted
- 26 Oct 2012
- Last updated
- 23 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Trial of 2% Chlorhexidine Gluconate-Impregnated Bath Cloths to Prevent MRSA Colonization on Complex Continuing Care Units of Baycrest Hospital
- ClinicalTrials.gov ID
- NCT01717690
- Acronym / sponsor ID
- BCGC-CHG-2012
- Keywords
- MRSA, chlorhexidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- BaycrestUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 30 Oct 2012 (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 whether daily bathing with 2% chlorhexidine gluconate-impregnated antiseptic cleanser (CHG) significantly reduces incidence of colonization of hospitalized patients with methicillin-resistant Staphylococcus aureus (MRSA).
Investigators postulate that daily bathing with CHG significantly reduces incidence of colonization of hospitalized patients with MRSA.
Detailed description
Bathing patients with 2% chlorhexidine gluconate-impregnated cloths (CHG) is an established practice at Baycrest. Our previous studies have demonstrated strong MRSA-preventive properties of CHG bathing practice - the rate of MRSA transmission on intervention units dropped from 4.99 to 0.88 cases per 1,000 patient days - an overall rate reduction of 82%.
Although CHG will continue to be used as part of an established clinical practice in our hospital, its impact on MRSA prevention merits further evaluation in complex continuing care (CCC) settings endemic for MRSA. Investigators propose a cluster-randomized, prospective, open-label, two-arm clinical trial (RCT) on three geographically separate, but otherwise comparable, CCC units - one intervention unit using CHG, and two control units using non-antiseptic cleanser. The RCT is expected to conclusively answer whether daily bathing with CHG significantly reduces incidence of MRSA colonization.
By cluster randomization investigators imply randomly assigning interventions to the three patient care units. Investigators propose randomization of the units as it is not feasible to randomly assign the individual participants to intervention vs control arms.
For a meaningful interpretation of the RCT findings, patient populations on the three floors will be compared at the beginning, during, and at the end of the study. The following variables will be used to compare patient populations:
- Colonization pressure (CP) is a measure of the MRSA reservoir on the unit. CP will be calculated at the onset of the RCT and then bi-weekly (Number of MRSA patient-days × 100 ÷ Total Number of Patient Days).
- Average Braden scale score (BSS) for patients on each unit is measured to predict a pressure ulcer risk. It is one of the measures of patient's clinical complexity. It is calculated by examining six patient criteria (sensory perception, skin moisture, physical activity, mobility, nutrition, friction and shear). BSS will be calculated at the onset of the RCT and then monthly.
- Average Case Mix Index (CMI) is a value reflecting the daily relative weight of resources used by an individual patient compared to a base resource level (the average resource use of the patient population). The CMI value is not a dollar amount; rather it is a relative value and an indirect marker of patient's clinical complexity. CMI will be calculated at the onset of the RCT and then quarterly.
Patient information will be de-identified for privacy reasons, before analysis of the study data - logistic regression, to compare the rates of MRSA incidence and time to MRSA conversion on intervention and control units.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHG antiseptic body cleanser | Active comparator | Drug: CHG antiseptic body cleanserOne randomly selected intervention unit in Complex Continuing Care program where all patients (MRSA-positive and MRSA-negative) will be bathed daily with an antiseptic body cleanser (CHG). Only MRSA-negative patients at enrollment will be included in the study analysis, and only their outcomes (MRSA status and time to conversion) will be analyzed. Antiseptic body cleanser - 2% Chlorhexidine Gluconate in a non-alcohol and non-alkaline base, delivered to skin surface through the bath cloths impregnated with this antiseptic solution. |
| Non-antiseptic body cleanser | No intervention | –Two control units in Complex Continuing Care program where all patients (MRSA-positive and MRSA-negative) will be bathed daily with a non-antiseptic body cleanser (Comfort Bath ®). Only MRSA-negative patients at enrollment will be included in the study analysis, and only their outcomes (MRSA status and time to conversion) will be analyzed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- MRSA-negative (at enrollment) inpatient of Complex Continuing Care program
Key exclusion criteria (1 listed)
- MRSA-positive (at enrollment) inpatient of Complex Continuing Care program
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 |
|---|---|---|
| CHG antiseptic body cleanserAlso: Chlorhexidine gluconate cloths, Drug Identification Number (Health Canada): 02245741The intervention consists of daily bathing of all patients (MRSA-positive and MRSA-negative) on the intervention unit with CHG. | Drug | CHG antiseptic body cleanser |
Primary outcome
Incidence of MRSA colonization
Time frame: 12 months
Primary outcome measure will be incidence of MRSA colonization measured through bi-weekly point-prevalence surveys on each of the three units. All new admissions and re-admissions to the units will also be screened. Protective properties of CHG bathing are expected to significantly reduce the incidence of MRSA transmission in the intervention arm, compared to control arms.
1 secondary outcome
Time to MRSA conversion
Time frame: 12 months
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 23 Feb 2015.
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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.
Chingiz Amirov, MPH, CIC principal investigator
Baycrest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CHG antiseptic body cleanser in people with Staph Aureus Methicillin Resistant Colonization, run by Baycrest at 1 site in Canada.
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 23 Feb 2015. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of MRSA colonization (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2015.