The Natural History of Community-Associated MRSA Infections and Decolonization Strategies
StLStaRS
1 other identifier
interventional
300
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2007
Longer than P75 for not_applicable
2 active sites
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
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 8, 2007
CompletedFirst Posted
Study publicly available on registry
August 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
March 29, 2011
CompletedJuly 30, 2015
July 1, 2015
2.3 years
August 8, 2007
March 2, 2011
July 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection
1, 4 and 6 month follow-ups
Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention
4 month follow-up
Study Arms (4)
1: Hygiene Education
ACTIVE COMPARATORIntensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
2: Hygiene education + mupirocin
ACTIVE COMPARATORApplication of mupirocin in the nasal mucosa alone
Education + mupirocin + chlorhexidine
ACTIVE COMPARATORA combination of nasal application of mupirocin and chlorhexidine showers
4: Education + mupirocin + bleach baths
ACTIVE COMPARATORA combination of nasal application of mupirocin and bathing in dilute bleach water
Interventions
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.
Apply Clorhexidine wash to entire body once daily for 5 days.
Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.
Repeat hygiene methods for 5 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Related Publications (1)
Fritz SA, Camins BC, Eisenstein KA, Fritz JM, Epplin EK, Burnham CA, Dukes J, Storch GA. Effectiveness of measures to eradicate Staphylococcus aureus carriage in patients with community-associated skin and soft-tissue infections: a randomized trial. Infect Control Hosp Epidemiol. 2011 Sep;32(9):872-80. doi: 10.1086/661285.
PMID: 21828967DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stephanie Fritz
- Organization
- Washington University
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard C. Camins, MD, MSCR
Assistant Professor of Medicine, Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine
- PRINCIPAL INVESTIGATOR
Gregory A. Storch, MD
Professor of Medicine and Molecular Microbiology, Chief of Division of Pediatric Infectious Diseases, Department of Medicine, 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 8, 2007
First Posted
August 9, 2007
Study Start
March 1, 2007
Primary Completion
June 1, 2009
Study Completion
December 1, 2010
Last Updated
July 30, 2015
Results First Posted
March 29, 2011
Record last verified: 2015-07