Methicillin Resistant Staphylococcus Aureus Skin InfectionsPhase 3PRIMONCT00560599
A Randomized Clinical Trial to Prevent Recurrent CA-MRSA Infection
A Phase 3 study testing mupirocin and chlorhexidine, household cleaning and disinfection and mupirocin, chlorhexidine, & household cleaning/disinfection in people with Methicillin Resistant Staphylococcus Aureus Skin Infections, run by loren g miller at 6 sites in United States.
Trial summary
This clinical trial tests the hypotheses that 1) body decolonization of patients with recurrent community-associated (CA) MRSA infections and their household members and 2) environmental decolonization of the patients' households will significantly reduce the likelihood of recurrent CA-MRSA infection. Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Methicillin Resistant Staphylococcus Aureus Skin Infections
- What is being tested?
- mupirocin and chlorhexidine, household cleaning and disinfection and mupirocin, chlorhexidine, & household cleaning/disinfection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2007to Dec 2012
- Phase
- Phase 3
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Is a member of Kaiser Permanente Southern California (KPSC)
- Have at least 1 culture positive for MRSA in the prior 12 months and at least one skin infection in the prior 12 months. The culture(s) and/or skin infection(s) will:
- Be associated with mutually exclusive patient encounters that are separated by at least 21 days. The encounters include: outpatient visits to primary care provider; outpatient visits to emergency departments or urgent care facilities; inpatient hospitalizations (admission date is considered the encounter date)
- AND
- Each patient encounter defined in section A is associated with EITHER:
- EITHER receipt of a prescription (or course) of antibiotics for a clinical infection.
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- OR
- A visit to an outpatient setting (including primary care provider visits, emergency department visits, phone consultations, and urgent care visits) for a skin or skin structure infection.
- Age is 1 month or older
- Ability and willingness to take intranasal medications, topical body washes, and environmental decontamination measures.
- Ability and willingness of subject or legal guardian/representative to give written informed consent.
- Ability and willingness to participate in the study according to treatment allocation even if not randomized to an active intervention.
Who cannot join
- Current residence in a KPSC-associated chronic care facility or other chronic-care facility (e.g., a rehabilitation facility or nursing home)
- Receipt of hemodialysis or peritoneal dialysis in the prior 12 months
- Any of the following severe underlying conditions: Organ transplantation, active or recent malignancy, cancer, or inflammatory disorder that has required (or would have require treatment) in the prior 12 months, with radiation therapy, surgery, chemotherapy, systemic immunomodulatory therapy (e.g., tumor necrosis factor (TNF)-alpha inhibitors for rheumatic and inflammatory diseases), or corticosteroid therapy (defined as > 7.5 mg prednisone (or equivalent doses of a non-prednisone corticosteroid) daily for adults, or above physiologic levels of prednisone or other corticosteroid therapy daily for children).
- Any of the following major surgical procedure in the prior 12 months: orthopedic procedure, cardiothoracic surgery, or abdominal surgery.
- Use of the following drugs or procedures within 120 days prior to study entry: topical mupirocin (Bactroban or Bactroban Nasal), Chlorhexidine (e.g., Hibiclens or other branded or generic formulations) body washes, or environmental decontamination of the household with ethyl alcohol (e.g., Lysol Brand Disinfectant Spray for Kitchens or other branded or generic formulations), bleach or dilute bleach solutions, or similar regimens
- Current use of systemic antibiotics used specifically to treat skin or skin structure infections, MRSA infections, or S. aureus infections. Patients on systemic therapy noted here must complete the systemic antibiotic therapy prior to enrollment.
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- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Current skin wound or lesion that is deeper than superficial layers of the skin (which is known to be a relative contraindication to topical Hibiclens). Subjects with deeper skin infection may be enrolled when their wound has healed sufficiently so that the wound is no deeper than the superficial skin layers
- Known hypersensitivity or allergic reaction to either topical mupirocin or mupirocin-containing products (e.g., Bactroban or Bactroban Nasal), or chlorhexidine or chlorhexidine-containing (e.g., Hibiclens) topical washes or products containing chlorhexidine.
- Concurrent use of other intranasal products (e.g., saline washes, topical decongestants, antihistamines, or anticholinergics). Patients who use these products who are willing to discontinue therapy for seven days while mupirocin is administered (if they are randomized to this medication) will be allowed to participate in consultation with the patient's provider.
- Chronic skin conditions associated with hypersensitivity to using topical cleansers or preparations.
- Known hypersensitivity among household members to the agents listed above, specifically mupirocin, chlorhexidine, and topical ethanol.
- "Heavy" or excessive use of body decolonizing agents such as triclosan-containing soap or Phisohex, as determined by the Study Site Coordinator.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Kaiser Permanente, Anaheim
Anaheim, California, 92807
Kaiser Permanente, Bellflower
Bellflower, California, 90706
Kaiser Permanente, Harbor City
Harbor City, California, 90710
Kaiser Permanente, Irvine
Irvine, California, 92618
Kaiser Permanente, Panorama City
Panorama City, California, 91402
Kaiser Permanente, West LA
West Los Angeles, California, 90034
About this study
Official title: A 2X2 Phase III Open-label Clinical Trial of Therapy for Patients With Recurrent Methicillin Resistant Staphylococcus Aureus Infections: Topical Nasal & Body Decolonization and/or Environmental Decontamination vs. Standard of Care
This clinical trial tests the hypotheses that 1) body decolonization of patients with recurrent community-associated (CA) MRSA infections and their household members and 2) environmental decolonization of the patients' households will significantly reduce the likelihood of recurrent CA-MRSA infection.
Read the detailed description
Staphylococcus aureus is a ubiquitous pathogen, and causes infections of the skin, lung, bloodstream, and other body parts. Over the past decade,community-acquired methicillin resistant S. aureus (CA-MRSA) infections, which were previously extremely rare, are occurring commonly worldwide. CA-MRSA is the most common cause of skin infection in many locales in the U.S., including Southern California.
CA-MRSA strains are notable for their ability to spread in closed settings and cause recurrent infections among healthy persons. Management of recurrent CA-MRSA infection is challenging and optimal prevention strategies are undefined. Many experts recommend topical agents that decontaminate the body and/or anterior nares. Others suggest environmental decontamination to help control recurrences or transmission within households. However, there are no data that quantify the efficacy and safety of these approaches.
We will conduct a multi-center clinical trial to compare the efficacy and safety of body and environmental decolonization regimens in the prevention of CA-MRSA infection. This trial is being conducted at Kaiser Permanente Southern California (KPSC) sites among KPSC enrollees.
The study population will comprise of persons suffering from recurrent CA-MRSA infection. Household members of this "index subject" will also be offered the chance to enroll in the study. For this clinical trial, all subjects will be randomized in a 2 x 2 design to test: 1) chlorhexidine body washes and nasal mupirocin ointment vs. usual care, and 2) environmental cleansing with ethanol spray and aggressive laundering vs. no environmental cleansing. Household members, should they consent, will also be enrolled into the study into the same treatment arm as "index subjects". We will also perform selected secondary analyses, including studying the efficacy of the interventions at preventing infections in household members. Additionally, we will examine strain relatedness of colonizing and infecting CA-MRSA strains to better understand colonization dynamics within households.
- Being tested
- mupirocin and chlorhexidine, household cleaning and disinfection, mupirocin, chlorhexidine, & household cleaning/disinfection
- Keywords
- MRSA, Methicillin Resistant Staphylococcus aureus, Staphylococcus aureus, Skin Infections, Body Decolonization, Environmental Decolonization
- Medical subject headings
- Staphylococcal Infections, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mupirocin and chlorhexidineDrug
Mupirocin (Bactroban Nasal): twice a day for 7 days, apply one pea-sized amount of Bactroban Nasal ointment directly into one nostril and another pea-sized amount for the other nostril.
Chlorhexidine (Hibiclens): once a day for 14 days, rinse body with chlorhexidine.
household cleaning and disinfectionBehavioural
Environmental cleaning with topical ethanol and laundering of clothes and linen.
mupirocin, chlorhexidine, & household cleaning/disinfectionDrug
Mupirocin (Bactroban Nasal): twice a day for 7 days, apply one pea-sized amount of Bactroban Nasal ointment directly into one nostril and another pea-sized amount for the other nostril.
Chlorhexidine (Hibiclens): once a day for 14 days, rinse body with chlorhexidine.
Environmental cleaning with topical ethanol and laundering of clothes and linen.
| Study group | Role | What they receive |
|---|---|---|
| 1: Standard of care | No intervention | Standard of care (no body decolonization regimen) and Standard of care (no environmental decolonization regimen) |
| 2: Body decolonization regimen | Experimental | Body decolonization regimen and Standard of care (no environmental decolonization regimen) Receives: Drug: mupirocin and chlorhexidine |
| 3 Environmental decolonization regimen | Experimental | Standard of care (no body decolonization regimen) and Environmental decolonization regimen Receives: Behavioral: household cleaning and disinfection |
| 4 Body and Environmental decolonization regimens | Experimental | Body decolonization regimen and Environmental decolonization regimen Receives: Drug: mupirocin, chlorhexidine, & household cleaning/disinfection |
What is being measured
The primary outcome is the main question the study is designed to answer.
A new MRSA or skin infection consistent with MRSA infection.
Measured: during the 52-week follow up period
Secondary outcomes (1)
A new skin infection that was cultured and not found to be caused by MRSA.
Measured: during the 52-week follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startApr 2007
- Primary completionFeb 2012
- Study completionDec 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 Aureus Skin InfectionsStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- loren g miller
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor-investigator, loren g miller, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Jared Spotkov, M.D., Principal investigator, Kaiser PermanenteLoren Miller, M.D., M.P.H., Study chair, Harbor-UCLA Medical Center (LABiomed)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00560599
- Sponsor's protocol ID
- 12550-01
- Other IDs
- KPSC IRB: 4714, CDC: 1U01CI000384-01
- Acronym
- PRIMO
- Status last verified
- Mar 2025
- First submitted
- 16 Nov 2007
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2X2 Phase III Open-label Clinical Trial of Therapy for Patients With Recurrent Methicillin Resistant Staphylococcus Aureus Infections: Topical Nasal & Body Decolonization and/or Environmental Decontamination vs. Standard of Care
- ClinicalTrials.gov ID
- NCT00560599
- Acronym / sponsor ID
- PRIMO / 12550-01
- Keywords
- MRSA, Methicillin Resistant Staphylococcus aureus, Staphylococcus aureus, Skin Infections, Body Decolonization, Environmental Decolonization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- loren g millerUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- Apr 2007
- Primary completion
- Feb 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Nov 2007 (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.
This clinical trial tests the hypotheses that 1) body decolonization of patients with recurrent community-associated (CA) MRSA infections and their household members and 2) environmental decolonization of the patients' households will significantly reduce the likelihood of recurrent CA-MRSA infection.
Detailed description
Staphylococcus aureus is a ubiquitous pathogen, and causes infections of the skin, lung, bloodstream, and other body parts. Over the past decade,community-acquired methicillin resistant S. aureus (CA-MRSA) infections, which were previously extremely rare, are occurring commonly worldwide. CA-MRSA is the most common cause of skin infection in many locales in the U.S., including Southern California.
CA-MRSA strains are notable for their ability to spread in closed settings and cause recurrent infections among healthy persons. Management of recurrent CA-MRSA infection is challenging and optimal prevention strategies are undefined. Many experts recommend topical agents that decontaminate the body and/or anterior nares. Others suggest environmental decontamination to help control recurrences or transmission within households. However, there are no data that quantify the efficacy and safety of these approaches.
We will conduct a multi-center clinical trial to compare the efficacy and safety of body and environmental decolonization regimens in the prevention of CA-MRSA infection. This trial is being conducted at Kaiser Permanente Southern California (KPSC) sites among KPSC enrollees.
The study population will comprise of persons suffering from recurrent CA-MRSA infection. Household members of this "index subject" will also be offered the chance to enroll in the study. For this clinical trial, all subjects will be randomized in a 2 x 2 design to test: 1) chlorhexidine body washes and nasal mupirocin ointment vs. usual care, and 2) environmental cleansing with ethanol spray and aggressive laundering vs. no environmental cleansing. Household members, should they consent, will also be enrolled into the study into the same treatment arm as "index subjects". We will also perform selected secondary analyses, including studying the efficacy of the interventions at preventing infections in household members. Additionally, we will examine strain relatedness of colonizing and infecting CA-MRSA strains to better understand colonization dynamics within households.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1: Standard of care | No intervention | –Standard of care (no body decolonization regimen) and Standard of care (no environmental decolonization regimen) |
| 2: Body decolonization regimen | Experimental | Drug: mupirocin and chlorhexidineBody decolonization regimen and Standard of care (no environmental decolonization regimen) |
| 3 Environmental decolonization regimen | Experimental | Behavioral: household cleaning and disinfectionStandard of care (no body decolonization regimen) and Environmental decolonization regimen |
| 4 Body and Environmental decolonization regimens | Experimental | Drug: mupirocin, chlorhexidine, & household cleaning/disinfectionBody decolonization regimen and Environmental decolonization regimen |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Is a member of Kaiser Permanente Southern California (KPSC)
- Have at least 1 culture positive for MRSA in the prior 12 months and at least one skin infection in the prior 12 months. The culture(s) and/or skin infection(s) will:
- Be associated with mutually exclusive patient encounters that are separated by at least 21 days. The encounters include: outpatient visits to primary care provider; outpatient visits to emergency departments or urgent care facilities; inpatient hospitalizations (admission date is considered the encounter date)
- AND
- EITHER receipt of a prescription (or course) of antibiotics for a clinical infection.
Key exclusion criteria (13 listed)
- Current residence in a KPSC-associated chronic care facility or other chronic-care facility (e.g., a rehabilitation facility or nursing home)
- Receipt of hemodialysis or peritoneal dialysis in the prior 12 months
- Any of the following severe underlying conditions: Organ transplantation, active or recent malignancy, cancer, or inflammatory disorder that has required (or would have require treatment) in the prior 12 months, with radiation therapy, surgery, chemotherapy, systemic immunomodulatory therapy (e.g., tumor necrosis factor (TNF)-alpha inhibitors for rheumatic and inflammatory diseases), or corticosteroid therapy (defined as > 7.5 mg prednisone (or equivalent doses of a non-prednisone corticosteroid) daily for adults, or above physiologic levels of prednisone or other corticosteroid therapy daily for children).
- Any of the following major surgical procedure in the prior 12 months: orthopedic procedure, cardiothoracic surgery, or abdominal surgery.
- Use of the following drugs or procedures within 120 days prior to study entry: topical mupirocin (Bactroban or Bactroban Nasal), Chlorhexidine (e.g., Hibiclens or other branded or generic formulations) body washes, or environmental decontamination of the household with ethyl alcohol (e.g., Lysol Brand Disinfectant Spray for Kitchens or other branded or generic formulations), bleach or dilute bleach solutions, or similar regimens
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 |
|---|---|---|
| mupirocin and chlorhexidineMupirocin (Bactroban Nasal): twice a day for 7 days, apply one pea-sized amount of Bactroban Nasal ointment directly into one nostril and another pea-sized amount for the other nostril. Chlorhexidine (Hibiclens): once a day for 14 days, rinse body with chlorhexidine. | Drug | 2: Body decolonization regimen |
| household cleaning and disinfectionEnvironmental cleaning with topical ethanol and laundering of clothes and linen. | Behavioural | 3 Environmental decolonization regimen |
| mupirocin, chlorhexidine, & household cleaning/disinfectionMupirocin (Bactroban Nasal): twice a day for 7 days, apply one pea-sized amount of Bactroban Nasal ointment directly into one nostril and another pea-sized amount for the other nostril. Chlorhexidine (Hibiclens): once a day for 14 days, rinse body with chlorhexidine. Environmental cleaning with topical ethanol and laundering of clothes and linen. | Drug | 4 Body and Environmental decolonization regimens |
Primary outcome
A new MRSA or skin infection consistent with MRSA infection.
Time frame: during the 52-week follow up period
1 secondary outcome
A new skin infection that was cultured and not found to be caused by MRSA.
Time frame: during the 52-week follow up period
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 10 Mar 2025.
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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.
Jared Spotkov, M.D. principal investigator
Kaiser Permanente
Loren Miller, M.D., M.P.H. study chair
Harbor-UCLA Medical Center (LABiomed)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mupirocin and chlorhexidine, household cleaning and disinfection and mupirocin, chlorhexidine, & household cleaning/disinfection in people with Methicillin Resistant Staphylococcus Aureus Skin Infections, run by loren g miller at 6 sites in United States.
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 12 inclusion and 13 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
A new MRSA or skin infection consistent with MRSA infection. (time frame: during the 52-week follow up period). 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 10 Mar 2025.