Methicillin-resistant Staphylococcus AureusNCT01232231
Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus (MRSA) in the Outpatient Setting
A study testing pharmacological decolonization treatment and Education in people with Methicillin-resistant Staphylococcus Aureus, run by Joseph Kim at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effectiveness of topical and oral antibiotics in eliminating carriage of methicillin-resistant Staphylococcus aureus (MRSA) among those living in the community. 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?
- pharmacological decolonization treatment and Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Nov 2012
- 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
- Prior MRSA infection (i.e index case)
- Identified as being colonized with MRSA on initial screen
Who cannot join
- Are pregnant or breastfeeding.
- Have indwelling catheters.
- Received prior decolonization treatment within last 6 months of enrollment.
- Have allergy to study medication.
- Are colonized with MRSA strain resistant to study medication.
- Have active infection requiring systemic antimicrobials.
- Are household contacts to index case.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus in the Outpatient Setting: a Randomized Controlled Study
The purpose of this study is to determine the effectiveness of topical and oral antibiotics in eliminating carriage of methicillin-resistant Staphylococcus aureus (MRSA) among those living in the community. We hypothesize that a greater proportion of those who receive intervention will eliminate MRSA carriage compared to those who do not receive any intervention.
- Being tested
- pharmacological decolonization treatment, Education
- Keywords
- methicillin-resistant Staphylococcus aureus, decolonization, random allocation, outpatient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacological decolonization treatmentDrug
Chlorhexidine gluconate 4% body scrub and 2% shampoo daily PLUS mupirocin 2%, fusidic acid 2%, or chlorhexidine gluconate 0.2% intranasally bid PLUS trimethoprim-sulfamethoxazole 160/800mg po bid or doxycycline 100mg po bid all for 7 days
EducationBehavioural
No pharmacological decolonization treatment but given education regarding personal hygiene and environmental cleaning
| Study group | Role | What they receive |
|---|---|---|
| decolonization treatment | Active comparator | topical antiseptic, intranasal antimicrobial, and oral antimicrobial that have activity against MRSA in addition to education regarding personal hygiene and environmental cleaning Receives: Drug: pharmacological decolonization treatment |
| education | Other | No decolonization treatment in addition to education regarding personal hygiene and environmental cleaning Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of MRSA carriage
Measured: 90 days after randomization
Secondary outcomes (1)
Occurrence of MRSA infection
Measured: Within 6 months of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joseph Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor-investigator, Joseph Kim, University of Calgary
- Investigators
- Thomas J Louie, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232231
- Sponsor's protocol ID
- E23134
- Status last verified
- Feb 2013
- First submitted
- 1 Nov 2010
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Strategy to Decolonize Methicillin-resistant Staphylococcus Aureus in the Outpatient Setting: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01232231
- Acronym / sponsor ID
- E23134
- Keywords
- methicillin-resistant Staphylococcus aureus, decolonization, random allocation, outpatient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Joseph KimUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- Jul 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 2 Nov 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 effectiveness of topical and oral antibiotics in eliminating carriage of methicillin-resistant Staphylococcus aureus (MRSA) among those living in the community. We hypothesize that a greater proportion of those who receive intervention will eliminate MRSA carriage compared to those who do not receive any intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| decolonization treatment | Active comparator | Drug: pharmacological decolonization treatmenttopical antiseptic, intranasal antimicrobial, and oral antimicrobial that have activity against MRSA in addition to education regarding personal hygiene and environmental cleaning |
| education | Other | Behavioral: EducationNo decolonization treatment in addition to education regarding personal hygiene and environmental cleaning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prior MRSA infection (i.e index case)
- Identified as being colonized with MRSA on initial screen
Key exclusion criteria (7 listed)
- Are pregnant or breastfeeding.
- Have indwelling catheters.
- Received prior decolonization treatment within last 6 months of enrollment.
- Have allergy to study medication.
- Are colonized with MRSA strain resistant to study medication.
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 |
|---|---|---|
| pharmacological decolonization treatmentChlorhexidine gluconate 4% body scrub and 2% shampoo daily PLUS mupirocin 2%, fusidic acid 2%, or chlorhexidine gluconate 0.2% intranasally bid PLUS trimethoprim-sulfamethoxazole 160/800mg po bid or doxycycline 100mg po bid all for 7 days | Drug | decolonization treatment |
| EducationNo pharmacological decolonization treatment but given education regarding personal hygiene and environmental cleaning | Behavioural | education |
Primary outcome
Eradication of MRSA carriage
Time frame: 90 days after randomization
1 secondary outcome
Occurrence of MRSA infection
Time frame: Within 6 months of randomization
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 15 Feb 2013.
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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.
Thomas J Louie, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacological decolonization treatment and Education in people with Methicillin-resistant Staphylococcus Aureus, run by Joseph Kim 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 2 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 15 Feb 2013. 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.
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?
Eradication of MRSA carriage (time frame: 90 days after randomization). 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 15 Feb 2013.