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

This study has been completed.
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT00560599
First received: November 16, 2007
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Los Angeles Biomedical Research Institute:

Primary Outcome Measures:
  • A new MRSA or skin infection consistent with MRSA infection. [ Time Frame: during the 52-week follow up period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • A new skin infection that was cultured and not found to be caused by MRSA. [ Time Frame: during the 52-week follow up period ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: April 2007
Study Completion Date: December 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   1 Month and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

AND

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.

OR

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560599

Locations
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
Investigators
Principal Investigator: Jared Spotkov, M.D. Kaiser Permanente Southern California
Study Chair: Loren Miller, M.D., M.P.H. Harbor-UCLA Medical Center (LABiomed)
  More Information

No publications provided

Responsible Party: Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT00560599     History of Changes
Other Study ID Numbers: 12550-01, KPSC IRB: 4714, CDC: 1U01CI000384-01
Study First Received: November 16, 2007
Last Updated: September 25, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

Additional relevant MeSH terms:
Skin Diseases, Infectious
Staphylococcal Infections
Infection
Skin Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Chlorhexidine
Chlorhexidine gluconate
Methicillin
Mupirocin
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014