Staphylococcus Aureus Decolonization Study

Not Applicable

Completed

• Conditions: Abscesses; MRSA Infection; Staphylococcus Aureus; Staphylococcal Skin Infections; Furunculosis
• Interventions: Drug: 2% Mupirocin Ointment; Drug: 4% Chlorhexidine liquid soap; Behavioral: Hygiene protocol

• Registration Number: NCT00731783
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-08-07
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-11
• Primary Completion: 2010-01
• Study Completion: 2010-12
• Results First Submitted: 2011-03-02
• Results First Submitted QC: 2011-03-02
• Results First Posted: 2011-03-23
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-23
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Household	2% Mupirocin Ointment	All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Household	4% Chlorhexidine liquid soap	All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Index patient only	2% Mupirocin Ointment	Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
Index patient only	4% Chlorhexidine liquid soap	Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
Index patient only	Hygiene protocol	Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
Household	Hygiene protocol	All members of the household (over the age of 6 months) will be asked to follow the study protocol.

Primary Outcome Measures

Name	Time	Method
Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures	1 month after enrollment.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Louis Children's Hospital; 🇺🇸 St. Louis, Missouri, United States