A Randomized Clinical Trial to Prevent Recurrent CA-MRSA Infection

NCT00560599 | Completed Phase 3 DMC

• 3 other identifiers: 12550-01KPSC IRB: 4714CDC: 1U01CI000384-01
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 6

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.

Conditions

Methicillin Resistant Staphylococcus Aureus Skin Infections

Keywords

MRSA; Methicillin Resistant Staphylococcus aureus; Staphylococcus aureus; Skin Infections; Body Decolonization; Environmental Decolonization

Outcome Measures

Primary Outcomes (1)

• A new MRSA or skin infection consistent with MRSA infection.

  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.

  during the 52-week follow up period

Study Arms (4)

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)

Drug: mupirocin and chlorhexidine

3 Environmental decolonization regimen

EXPERIMENTAL

Standard of care (no body decolonization regimen) and Environmental decolonization regimen

Behavioral: household cleaning and disinfection

4 Body and Environmental decolonization regimens

EXPERIMENTAL

Body decolonization regimen and Environmental decolonization regimen

Drug: mupirocin, chlorhexidine, & household cleaning/disinfection

Interventions

mupirocin and chlorhexidine DRUG

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.

2: Body decolonization regimen

household cleaning and disinfection BEHAVIORAL

Environmental cleaning with topical ethanol and laundering of clothes and linen.

3 Environmental decolonization regimen

mupirocin, chlorhexidine, & household cleaning/disinfection DRUG

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.

4 Body and Environmental decolonization regimens

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• loren g miller: lead
• Kaiser Permanente: collaborator

Study Sites (6)

Kaiser Permanente, Anaheim

Anaheim, California, 92807, United States

Location

Kaiser Permanente, Bellflower

Bellflower, California, 90706, United States

Location

Kaiser Permanente, Harbor City

Harbor City, California, 90710, United States

Location

Kaiser Permanente, Irvine

Irvine, California, 92618, United States

Location

Kaiser Permanente, Panorama City

Panorama City, California, 91402, United States

Location

Kaiser Permanente, West LA

West Los Angeles, California, 90034, United States

Location

MeSH Terms

Conditions

Staphylococcal Infections; Cellulitis

Interventions

Mupirocin; Chlorhexidine; Disinfection

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Biguanides; Guanidines; Amidines; Sterilization; Infection Control; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Officials

• Jared Spotkov, M.D.

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Loren Miller, M.D., M.P.H.

  Harbor-UCLA Medical Center (LABiomed)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2007
• First Posted: November 20, 2007
• Study Start: April 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

US (6)