Staphylococcus Aureus Decolonization Study
SuDS
Household vs. Individual Approach to Decolonization of Community-acquired Methicillin-resistant Staphylococcus Aureus.
1 other identifier
interventional
183
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 7, 2008
CompletedFirst Posted
Study publicly available on registry
August 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
March 23, 2011
CompletedApril 30, 2012
April 1, 2012
1.5 years
August 7, 2008
March 2, 2011
April 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures
3 month after enrollment.
Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures
6 month after enrollment.
Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures
12 month after enrollment.
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 - 3 Month After Enrollment.
3 month after enrollment
- +2 more secondary outcomes
Study Arms (2)
Index patient only
ACTIVE COMPARATOROnly the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
Household
ACTIVE COMPARATORAll members of the household (over the age of 6 months) will be asked to follow the study protocol.
Interventions
Apply ointment to the anterior nares twice daily for 5 days.
Bathe with liquid soap daily for 5 days.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Related Publications (1)
Fritz SA, Hogan PG, Hayek G, Eisenstein KA, Rodriguez M, Epplin EK, Garbutt J, Fraser VJ. Household versus individual approaches to eradication of community-associated Staphylococcus aureus in children: a randomized trial. Clin Infect Dis. 2012 Mar;54(6):743-51. doi: 10.1093/cid/cir919. Epub 2011 Dec 23.
PMID: 22198793DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephanie A. Fritz, M.D., M.S.C.I.
- Organization
- Washington University
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie A Fritz, MD
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Pediatrics
Study Record Dates
First Submitted
August 7, 2008
First Posted
August 11, 2008
Study Start
July 1, 2008
Primary Completion
January 1, 2010
Study Completion
December 1, 2010
Last Updated
April 30, 2012
Results First Posted
March 23, 2011
Record last verified: 2012-04