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Trial record 5 of 17 for:    "Connective Tissue Disease" | "Ethanol"

A Randomized Clinical Trial to Prevent Recurrent CA-MRSA Infection (PRIMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00560599
Recruitment Status : Completed
First Posted : November 20, 2007
Last Update Posted : September 26, 2013
Kaiser Permanente
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Methicillin Resistant Staphylococcus Aureus Skin Infections Drug: mupirocin and chlorhexidine Behavioral: household cleaning and disinfection Drug: mupirocin, chlorhexidine, & household cleaning/disinfection Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : April 2007
Actual Primary Completion Date : February 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Mupirocin

Arm Intervention/treatment
No Intervention: 1: Standard of care
Standard of care (no body decolonization regimen) and Standard of care (no environmental decolonization regimen)
Experimental: 2: Body decolonization regimen
Body decolonization regimen and Standard of care (no environmental decolonization regimen)
Drug: mupirocin and chlorhexidine

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.

Experimental: 3 Environmental decolonization regimen
Standard of care (no body decolonization regimen) and Environmental decolonization regimen
Behavioral: household cleaning and disinfection
Environmental cleaning with topical ethanol and laundering of clothes and linen.

Experimental: 4 Body and Environmental decolonization regimens
Body decolonization regimen and Environmental decolonization regimen
Drug: mupirocin, chlorhexidine, & household cleaning/disinfection

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.

Primary Outcome Measures :
  1. A new MRSA or skin infection consistent with MRSA infection. [ Time Frame: during the 52-week follow up period ]

Secondary Outcome Measures :
  1. A new skin infection that was cultured and not found to be caused by MRSA. [ Time Frame: during the 52-week follow up period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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:

A. 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)


Each patient encounter defined in section A is associated with EITHER:

B. EITHER receipt of a prescription (or course) of antibiotics for a clinical infection.


C. 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00560599

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United States, California
Kaiser Permanente, Anaheim
Anaheim, California, United States, 92807
Kaiser Permanente, Bellflower
Bellflower, California, United States, 90706
Kaiser Permanente, Harbor City
Harbor City, California, United States, 90710
Kaiser Permanente, Irvine
Irvine, California, United States, 92618
Kaiser Permanente, Panorama City
Panorama City, California, United States, 91402
Kaiser Permanente, West LA
West Los Angeles, California, United States, 90034
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Kaiser Permanente
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Principal Investigator: Jared Spotkov, M.D. Kaiser Permanente
Study Chair: Loren Miller, M.D., M.P.H. Harbor-UCLA Medical Center (LABiomed)

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Responsible Party: Los Angeles Biomedical Research Institute Identifier: NCT00560599     History of Changes
Other Study ID Numbers: 12550-01
KPSC IRB: 4714
CDC: 1U01CI000384-01
First Posted: November 20, 2007    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013

Keywords provided by Los Angeles Biomedical Research Institute:
Methicillin Resistant Staphylococcus aureus
Staphylococcus aureus
Skin Infections
Body Decolonization
Environmental Decolonization

Additional relevant MeSH terms:
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Connective Tissue Diseases
Communicable Diseases
Staphylococcal Infections
Skin Diseases, Infectious
Staphylococcal Skin Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pathologic Processes
Skin Diseases
Skin Diseases, Bacterial
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action