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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Abscesses, Furunculosis, Staphylococcus Aureus, Staphylococcal Skin Infections

Intervention / Treatment
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* Drug: Mupirocin ointment
* Genetic: Chlorhexidine showers
* Procedure: Bleach baths (dilute)
* Behavioral: Intensive education on personal hygiene


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1: Hygiene Education<br>Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group) | Behavioral: Intensive education on personal hygiene<br>* Repeat hygiene methods for 5 days.<br>|
| Active Comparator: 2: Hygiene education + mupirocin<br>Application of mupirocin in the nasal mucosa alone | Drug: Mupirocin ointment<br>* 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.<br>* Other names: Bactroban;Behavioral: Intensive education on personal hygiene<br>* Repeat hygiene methods for 5 days.<br>|
| Active Comparator: Education + mupirocin + chlorhexidine<br>A combination of nasal application of mupirocin and chlorhexidine showers | Drug: Mupirocin ointment<br>* 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.<br>* Other names: Bactroban;Genetic: Chlorhexidine showers<br>* Apply Clorhexidine wash to entire body once daily for 5 days.<br>* Other names: Hibiclens;Behavioral: Intensive education on personal hygiene<br>* Repeat hygiene methods for 5 days.<br>|
| Active Comparator: 4: Education + mupirocin + bleach baths<br>A combination of nasal application of mupirocin and bathing in dilute bleach water | Drug: Mupirocin ointment<br>* 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.<br>* Other names: Bactroban;Procedure: Bleach baths (dilute)<br>* Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.<br>* Other names: Clorox;Behavioral: Intensive education on personal hygiene<br>* Repeat hygiene methods for 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention | 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. | 1 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | 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. | 1, 4 and 6 month follow-ups | 
| Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention | 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. | 4 month follow-up |