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

Not Applicable

Completed

Conditions: Staphylococcal Skin Infections
Staphylococcus Aureus
Abscesses
Furunculosis

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

Registration Number: NCT00513799

Lead Sponsor: Washington University School of Medicine

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 300

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education + mupirocin + chlorhexidine	Mupirocin ointment	A combination of nasal application of mupirocin and chlorhexidine showers
4: Education + mupirocin + bleach baths	Mupirocin ointment	A combination of nasal application of mupirocin and bathing in dilute bleach water
2: Hygiene education + mupirocin	Intensive education on personal hygiene	Application of mupirocin in the nasal mucosa alone
Education + mupirocin + chlorhexidine	Chlorhexidine showers	A combination of nasal application of mupirocin and chlorhexidine showers
4: Education + mupirocin + bleach baths	Bleach baths (dilute)	A combination of nasal application of mupirocin and bathing in dilute bleach water
4: Education + mupirocin + bleach baths	Intensive education on personal hygiene	A combination of nasal application of mupirocin and bathing in dilute bleach water
1: Hygiene Education	Intensive education on personal hygiene	Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
Education + mupirocin + chlorhexidine	Intensive education on personal hygiene	A combination of nasal application of mupirocin and chlorhexidine showers
2: Hygiene education + mupirocin	Mupirocin ointment	Application of mupirocin in the nasal mucosa alone

Primary Outcome Measures

Name	Time	Method
Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention	1 month follow-up	Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention	4 month follow-up	Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.
Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection	1, 4 and 6 month follow-ups	Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit.