Staphylococcus Aureus Decolonization Study

Study Overview
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Brief Summary
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The purpose of this study is to determine whether measures to eliminate the Staph germ from the skin of the index patient (with a special ointment and soap) are more effective when performed by everyone in the household rather than the patient alone, and whether these methods are effective in preventing future Staph infections. The investigators hypothesize that there will be a greater number of households who are successful in eradicating the staph germ from the index patient when all members of the household participate than households where only the index patient is treated.

Detailed Description
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Methicillin-resistant Staphylococcus aureus (MRSA) was once uniformly associated with hospital-acquired infections; however, MRSA strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA). CA-MRSA has become a major source of morbidity and mortality in our pediatric population. An important prerequisite for S. aureus infection may be nasal carriage of the organism. A variety of decolonization strategies have been used for infection prophylaxis, primarily in patients undergoing hemodialysis or surgery, with varying results. However, there are no published randomized eradication trials evaluating the decolonization and prevention of CA-MRSA infections in immunocompetent children in the outpatient setting. While the transmission of CA-MRSA within households has been reported, its contribution to recurrent CA-MRSA infection among household members is undetermined. The investigators hypothesize that spread of CA-MRSA among household members leads to recolonization or failure of decolonization in children undergoing eradication efforts. Specific Aim: In pediatric patients presenting with a MRSA skin or soft tissue infection, compare the effectiveness of decolonization measures performed by an entire household in comparison to measures directed at the index patient alone. The investigators will conduct a randomized, controlled trial to test the hypothesis that decolonization measures performed by the entire household, specifically application of intranasal mupirocin ointment and bathing with chlorhexidine liquid soap, in addition to education and basic hygiene interventions, will be twice as effective in eradicating CA-MRSA carriage in the index patient than if the measures are performed only by the index patient.

Official Title
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Household vs. Individual Approach to Decolonization of Community-acquired Methicillin-resistant Staphylococcus Aureus.

Conditions
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Staphylococcal Skin Infections, Abscesses, Furunculosis, Staphylococcus Aureus, MRSA Infection

Intervention / Treatment
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* Drug: 2% Mupirocin Ointment
* Drug: 4% Chlorhexidine liquid soap
* Behavioral: Hygiene protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Screening: Children aged 6 months to 21 years presenting with an active skin or soft tissue infection. Enrollment: Positive MRSA culture from the abscess and from either the axilla, anterior nares or groin area (signifying both infection and colonization with MRSA). Exclusion Criteria: Infants less than 6 months of age Dialysis or residence in a long term care facility over the past year Use of chlorhexidine or mupirocin in the past one month Pregnancy Immunodeficiency History of an adverse reaction to chlorhexidine or mupirocin.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 21 Years

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: Index patient only<br>Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen. | Drug: 2% Mupirocin Ointment<br>* Apply ointment to the anterior nares twice daily for 5 days.<br>* Other names: Bactroban;Drug: 4% Chlorhexidine liquid soap<br>* Bathe with liquid soap daily for 5 days.<br>* Other names: Hibiclens;Behavioral: Hygiene protocol<br>* Follow key hygiene tips indefinitely. Tips are: Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. Use liquid(pour or pump) soaps instead of bar soaps. Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. Do not share personal care items such as razors and brushes. Wash all sheets and towels in hot water. Wash sheets every week. Use towels and wash cloths only once before washing and do not share.<br>|
| Active Comparator: Household<br>All members of the household (over the age of 6 months) will be asked to follow the study protocol. | Drug: 2% Mupirocin Ointment<br>* Apply ointment to the anterior nares twice daily for 5 days.<br>* Other names: Bactroban;Drug: 4% Chlorhexidine liquid soap<br>* Bathe with liquid soap daily for 5 days.<br>* Other names: Hibiclens;Behavioral: Hygiene protocol<br>* Follow key hygiene tips indefinitely. Tips are: Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. Use liquid(pour or pump) soaps instead of bar soaps. Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. Do not share personal care items such as razors and brushes. Wash all sheets and towels in hot water. Wash sheets every week. Use towels and wash cloths only once before washing and do not share.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures | 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. | 1 month after enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures | 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. | 3 month after enrollment. | 
| Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures | 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. | 6 month after enrollment. | 
| Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures | 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. | 12 month after enrollment. | 
| Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment. | Recurrence of CA-MRSA Skin or Soft Tissue Infection | 1 month after enrollment | 
| Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment. | Recurrence of CA-MRSA Skin or Soft Tissue Infection | 3 month after enrollment | 
| Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment. | Recurrence of CA-MRSA Skin or Soft Tissue Infection | 6 month after enrollment | 
| Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment. | Recurrence of CA-MRSA Skin or Soft Tissue Infection | 12 month after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abscesses, Furunculosis, Staphylococcus aureus colonization, Staphylococcal Skin Infections, MRSA