Official Title: “The Natural History of Community-Associated Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections and an Evaluation of Decolonization Strategies”

The purpose of this study is to determine the natural history of community-associated Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate of recurrent infections in those colonized with S. aureus.

In addition, this study will evaluate the efficiency of commonly prescribed decolonization measures in patients presenting with S. aureus skin and soft tissue infections.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2009

Infections with community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) range in severity from superficial skin abscesses to invasive soft tissue infections like cellulitis and pyomyositis. There has been a large increase in the number of patients presenting to our institution with CA-MRSA infections. Colonization with S. aureus (SA) may be linked to the development of infection but data on this phenomenon are limited. The recurrence rate for CA-MRSA soft tissue infections is unknown. A variety of decolonization strategies have been used for infection prophylaxis with varying results, primarily in patients undergoing hemodialysis or surgery. This study seeks to determine the recurrence rate of soft tissue infections among patients with CA-MRSA infections and to determine a reasonable and efficacious decolonization strategy to eradicate CA-MRSA from previously infected patients.

The proposed methods for decolonization will be tested in a randomized controlled trial with four intervention arms. The intervention arms are: (1) intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group"), (2) application of mupirocin in the nasal mucosa alone, (3) a combination of nasal application of mupirocin and chlorhexidine showers, and (4) a combination of nasal application of mupirocin and bathing in dilute bleach water. The "control" group as well as the three other arms will receive intensive hygiene education.

Decolonization with mupirocin ointment and chlorhexidine showers or dilute bleach baths in combination are likely to be more successful than either the application of nasal mupirocin ointment alone or hygiene measures alone. It is expected that these decolonization methods will result in a 50% relative reduction in MRSA colonization at 6 months.

Intervention(s) in this Clinical Trial

• Drug: Mupirocin ointment
  • Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.
• Procedure: Chlorhexidine showers
  • Apply Clorhexidine wash to entire body once daily for 5 days.
• Procedure: Bleach baths (dilute)
  • Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.
• Behavioral: Intensive education on personal hygiene
  • Repeat hygiene methods for 5 days.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
• Active Comparator: 2
  • Application of mupirocin in the nasal mucosa alone
• Active Comparator: 3
  • A combination of nasal application of mupirocin and chlorhexidine showers
• Active Comparator: 4
  • A combination of nasal application of mupirocin and bathing in dilute bleach water

Primary Measures

• Decolonization of Staphylococcus aureus
  • Time Frame: 4 months
    Safety Issue?: No

Secondary Measures

• Prevention of recurrent Staphylococcus aureus skin or soft tissue infection
  • Time Frame: 6 months
    Safety Issue?: No

Inclusion Criteria:

• Any patient who presents with at least one serious skin or soft tissue infection requiring incision and drainage at an affiliated institution or clinic in the St.
• Louis metropolitan area

Exclusion Criteria:

• Patients with permanent indwelling catheters or percutaneous medical devices
• Patients with a history of dialysis treatments, long term care facility admission, or presents with a surgical wound infection within the past year
• Patients who are pregnant

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Washington University School of Medicine

Overall Clinical Trial Officials and Contacts

Bernard C. Camins, MD, MSCR Principal Investigator Assistant Professor of Medicine, Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine  

Overall Contact: Stephanie A. Fritz, MD (314) 454-4115 Fritz_S@kids.wustl.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00513799

Study ID Number: 9000C4

ClinicalTrials.gov Identifier: NCT00513799

Health Authority: United States: Institutional Review Board