Methicillin-resistant Staphylococcus AureusNCT01438515
Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
A study testing Rifampin, Doxycycline and 2% mupirocin ointment in people with Methicillin-resistant Staphylococcus Aureus, run by Horizon Health Network at 1 site in Canada.
Trial summary
MRSA decolonization may reduce the risk of subsequent MRSA infection and further transmission. A recent randomized controlled trial demonstrated that systemic decolonization may be safe and effective among hospitalized patients when compared to no treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methicillin-resistant Staphylococcus Aureus
- What is being tested?
- Rifampin, Doxycycline and 2% mupirocin ointment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2008to 31 Dec 2019
- 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
- Any patient colonized with MRSA
Who cannot join
- Currently on treatment with antibiotics
- Pregnant or breastfeeding women
- Active infection
- Hepatic cirrhosis or abnormal INR due to liver disease
- Decolonization in the previous two (2) months
- MRSA bacteria resistant to one or more of the study medications
- AST and ALT levels more than five times the upper limit of normal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Chlorhexidine Gluconate, Intranasal Mupirocin, Rifampin and Doxycycline Versus Chlorhexidine Gluconate and Intranasal Mupirocin Alone for the Eradication of Methicillin-resistant Staphylococcus Aureus Among an Ambulatory Patient Population
MRSA decolonization may reduce the risk of subsequent MRSA infection and further transmission. A recent randomized controlled trial demonstrated that systemic decolonization may be safe and effective among hospitalized patients when compared to no treatment. As a large number of the investigators patients require re-admission and further transmission may take place in the community, the investigators are comparing the standard decolonization protocol for MRSA eradication to the systemic decolonization protocol among an ambulatory population.
Standard decolonization protocols, which use only topical agents, are limited in efficacy. The method of systemic decolonization to be studied here appears to have greater efficacy than the standard approach using only topical agents. However, concerns have been raised that the increased use of systemic antibiotics may lead to increased levels of drug resistance adverse effects, without sustained decolonization. This study seeks to provide further data to help answer these questions and provide guidance for further policy development and implementation.
- Being tested
- Rifampin, Doxycycline, 2% mupirocin ointment, 4% chlorhexidine gluconate
- Keywords
- MRSA, doxycycline, rifampin, mupirocin, chlorhexidine gluconate, decolonization, methicillin-resistant staphylococcus aureus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifampinDrug
600mg po once daily x 7 days
DoxycyclineDrug
100mg po twice daily x 7 days
2% mupirocin ointmentOther
~ 1cm applied to the anterior nares twice daily for 7 days
4% chlorhexidine gluconateOther
Daily full body wash (including hair) for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Systemic decolonization | Experimental | 7-day course of 4% chlorhexidine gluconate daily washes and 2% mupirocin ointment to the anterior nares twice daily in addition to oral rifampin (600mg daily), and doxycycline (100mg twice daily) Receives: Drug: Rifampin; Drug: Doxycycline; Other: 2% mupirocin ointment; Other: 4% chlorhexidine gluconate |
| Standard decolonization | Active comparator | 7-day course of 2% mupirocin ointment to the anterior nares twice daily and 4% chlorhexidine gluconate washes once per day. Receives: Other: 2% mupirocin ointment; Other: 4% chlorhexidine gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months
To compare standard versus systemic decolonization for their ability to sustain MRSA decolonization up to one year post-decolonization.
Measured: 12 months
Secondary outcomes (1)
Changes in susceptibility patterns of MRSA isolates.
Study isolates will be evaluated with regards to mupirocin, rifampin and tetracycline resistance patterns, where individuals remain colonized, or re-colonize subsequent to implementation of the decolonization protocol.
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 posted22 Sep 2011 (estimated)
- Study startAug 2008
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duncan Webster, Horizon Health Network
- Investigators
- Duncan Webster, MA, MD, Principal investigator, Horizon Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438515
- Sponsor's protocol ID
- 2008-1265
- Status last verified
- Feb 2020
- First submitted
- 21 Sep 2011
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Simor AE, Phillips E, McGeer A, Konvalinka A, Loeb M, Devlin HR, Kiss A. Randomized controlled trial of chlorhexidine gluconate for washing, intranasal mupirocin, and rifampin and doxycycline versus no treatment for the eradication of methicillin-resistant Staphylococcus aureus colonization. Clin Infect Dis. 2007 Jan 15;44(2):178-85. doi: 10.1086/510392. Epub 2006 Dec 14.
PubMed 17173213
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Chlorhexidine Gluconate, Intranasal Mupirocin, Rifampin and Doxycycline Versus Chlorhexidine Gluconate and Intranasal Mupirocin Alone for the Eradication of Methicillin-resistant Staphylococcus Aureus Among an Ambulatory Patient Population
- ClinicalTrials.gov ID
- NCT01438515
- Acronym / sponsor ID
- 2008-1265
- Keywords
- MRSA, doxycycline, rifampin, mupirocin, chlorhexidine gluconate, decolonization, methicillin-resistant staphylococcus aureus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Sep 2011 (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.
MRSA decolonization may reduce the risk of subsequent MRSA infection and further transmission. A recent randomized controlled trial demonstrated that systemic decolonization may be safe and effective among hospitalized patients when compared to no treatment. As a large number of the investigators patients require re-admission and further transmission may take place in the community, the investigators are comparing the standard decolonization protocol for MRSA eradication to the systemic decolonization protocol among an ambulatory population.
Standard decolonization protocols, which use only topical agents, are limited in efficacy. The method of systemic decolonization to be studied here appears to have greater efficacy than the standard approach using only topical agents. However, concerns have been raised that the increased use of systemic antibiotics may lead to increased levels of drug resistance adverse effects, without sustained decolonization. This study seeks to provide further data to help answer these questions and provide guidance for further policy development and implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic decolonization | Experimental | Drug: Rifampin, Drug: Doxycycline, Other: 2% mupirocin ointment, Other: 4% chlorhexidine gluconate7-day course of 4% chlorhexidine gluconate daily washes and 2% mupirocin ointment to the anterior nares twice daily in addition to oral rifampin (600mg daily), and doxycycline (100mg twice daily) |
| Standard decolonization | Active comparator | Other: 2% mupirocin ointment, Other: 4% chlorhexidine gluconate7-day course of 2% mupirocin ointment to the anterior nares twice daily and 4% chlorhexidine gluconate washes once per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient colonized with MRSA
Key exclusion criteria (7 listed)
- Currently on treatment with antibiotics
- Pregnant or breastfeeding women
- Active infection
- Hepatic cirrhosis or abnormal INR due to liver disease
- Decolonization in the previous two (2) months
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 |
|---|---|---|
| Rifampin600mg po once daily x 7 days | Drug | Systemic decolonization |
| Doxycycline100mg po twice daily x 7 days | Drug | Systemic decolonization |
| 2% mupirocin ointment~ 1cm applied to the anterior nares twice daily for 7 days | Other | Standard decolonization, Systemic decolonization |
| 4% chlorhexidine gluconateDaily full body wash (including hair) for 7 days | Other | Standard decolonization, Systemic decolonization |
Primary outcome
Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months
Time frame: 12 months
To compare standard versus systemic decolonization for their ability to sustain MRSA decolonization up to one year post-decolonization.
1 secondary outcome
Changes in susceptibility patterns of MRSA isolates.
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 17 Feb 2020.
- Background: PubMed 17173213Simor AE, Phillips E, McGeer A, Konvalinka A, Loeb M, Devlin HR, Kiss A. Randomized controlled trial of chlorhexidine gluconate for washing, intranasal mupirocin, and rifampin and doxycycline versus no treatment for the eradication of methicillin-resistant Staphylococcus aureus colonization. Clin Infect Dis. 2007 Jan 15;44(2):178-85. doi: 10.1086/510392. Epub 2006 Dec 14.
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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.
Duncan Webster, MA, MD principal investigator
Horizon Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifampin, Doxycycline and 2% mupirocin ointment in people with Methicillin-resistant Staphylococcus Aureus, run by Horizon Health Network 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 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 17 Feb 2020. 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?
Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months (time frame: 12 months). 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 NCT01438515, 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 17 Feb 2020.