Staphylococcus Aureus Clinical Trial
— SuDSOfficial title:
Household vs. Individual Approach to Decolonization of Community-acquired Methicillin-resistant Staphylococcus Aureus.
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.
Status | Completed |
Enrollment | 183 |
Est. completion date | December 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 21 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | St. Louis Children's Hospital | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Secondary | 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. | No |
Secondary | 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. | No |
Secondary | 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. | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
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