The Natural History of Community-Associated MRSA Infections and Decolonization Strategies

Condition(s) targeted: Abscesses; Furunculosis; Staphylococcus Aureus; Staphylococcal Skin Infections

Intervention: Mupirocin ointment (Drug); Chlorhexidine showers (Procedure); Bleach baths (dilute) (Procedure); Intensive education on personal hygiene (Behavioral)

Phase: N/A

Status: Recruiting

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
Bernard C. Camins, MD, MSCR, Principal Investigator, Affiliation: Assistant Professor of Medicine, Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine
Gregory A. Storch, MD, Principal Investigator, Affiliation: Professor of Medicine and Molecular Microbiology, Chief of Division of Pediatric Infectious Diseases, Department of Medicine, Washington University School of Medicine

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

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.

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

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

Primary outcome: Decolonization of Staphylococcus aureus

Secondary outcome: Prevention of recurrent Staphylococcus aureus skin or soft tissue infection

Detailed description: 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.

Minimum age: 6 Months. Maximum age: N/A. Gender(s): Both.

Criteria:

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

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

Barnes-Jewish Hospital, St. Louis, Missouri 63110, United States; Recruiting

St. Louis Children's Hospital, St. Louis, Missouri 63110, United States; Recruiting

Starting date: March 2007
Ending date: January 2010
Last updated: April 13, 2009