The Natural History of Community-Associated MRSA Infections and Decolonization Strategies (StLStaRS)
Primary Purpose
Abscesses, Furunculosis, Staphylococcus Aureus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mupirocin ointment
Chlorhexidine showers
Bleach baths (dilute)
Intensive education on personal hygiene
Sponsored by
About this trial
This is an interventional treatment trial for Abscesses
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Barnes-Jewish Hospital
- St. Louis Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1: Hygiene Education
2: Hygiene education + mupirocin
Education + mupirocin + chlorhexidine
4: Education + mupirocin + bleach baths
Arm Description
Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
Application of mupirocin in the nasal mucosa alone
A combination of nasal application of mupirocin and chlorhexidine showers
A combination of nasal application of mupirocin and bathing in dilute bleach water
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection
Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit.
Number of Participants Eradicated of S. Aureus Carriage - 4 Months 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.
Full Information
NCT ID
NCT00513799
First Posted
August 8, 2007
Last Updated
July 7, 2015
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00513799
Brief Title
The Natural History of Community-Associated MRSA Infections and Decolonization Strategies
Acronym
StLStaRS
Official Title
The Natural History of Community-Associated Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections and an Evaluation of Decolonization Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Infections with community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) range in severity from superficial skin abscesses to invasive soft tissue infections like cellulitis and pyomyositis. There has been a large increase in the number of patients presenting to our institution with CA-MRSA infections. Colonization with S. aureus (SA) may be linked to the development of infection but data on this phenomenon are limited. The recurrence rate for CA-MRSA soft tissue infections is unknown. A variety of decolonization strategies have been used for infection prophylaxis with varying results, primarily in patients undergoing hemodialysis or surgery. This study seeks to determine the recurrence rate of soft tissue infections among patients with CA-MRSA infections and to determine a reasonable and efficacious decolonization strategy to eradicate CA-MRSA from previously infected patients.
The proposed methods for decolonization will be tested in a randomized controlled trial with four intervention arms. The intervention arms are: (1) intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group"), (2) application of mupirocin in the nasal mucosa alone, (3) a combination of nasal application of mupirocin and chlorhexidine showers, and (4) a combination of nasal application of mupirocin and bathing in dilute bleach water. The "control" group as well as the three other arms will receive intensive hygiene education.
Decolonization with mupirocin ointment and chlorhexidine showers or dilute bleach baths in combination are likely to be more successful than either the application of nasal mupirocin ointment alone or hygiene measures alone. It is expected that these decolonization methods will result in a 50% relative reduction in MRSA colonization at 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abscesses, Furunculosis, Staphylococcus Aureus, Staphylococcal Skin Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: Hygiene Education
Arm Type
Active Comparator
Arm Description
Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
Arm Title
2: Hygiene education + mupirocin
Arm Type
Active Comparator
Arm Description
Application of mupirocin in the nasal mucosa alone
Arm Title
Education + mupirocin + chlorhexidine
Arm Type
Active Comparator
Arm Description
A combination of nasal application of mupirocin and chlorhexidine showers
Arm Title
4: Education + mupirocin + bleach baths
Arm Type
Active Comparator
Arm Description
A combination of nasal application of mupirocin and bathing in dilute bleach water
Intervention Type
Drug
Intervention Name(s)
Mupirocin ointment
Other Intervention Name(s)
Bactroban
Intervention Description
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.
Intervention Type
Genetic
Intervention Name(s)
Chlorhexidine showers
Other Intervention Name(s)
Hibiclens
Intervention Description
Apply Clorhexidine wash to entire body once daily for 5 days.
Intervention Type
Procedure
Intervention Name(s)
Bleach baths (dilute)
Other Intervention Name(s)
Clorox
Intervention Description
Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.
Intervention Type
Behavioral
Intervention Name(s)
Intensive education on personal hygiene
Intervention Description
Repeat hygiene methods for 5 days.
Primary Outcome Measure Information:
Title
Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention
Description
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.
Time Frame
1 month follow-up
Secondary Outcome Measure Information:
Title
Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection
Description
Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit.
Time Frame
1, 4 and 6 month follow-ups
Title
Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention
Description
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.
Time Frame
4 month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard C. Camins, MD, MSCR
Organizational Affiliation
Assistant Professor of Medicine, Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregory A. Storch, MD
Organizational Affiliation
Professor of Medicine and Molecular Microbiology, Chief of Division of Pediatric Infectious Diseases, Department of Medicine, Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes-Jewish Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis Children's Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21828967
Citation
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.
Results Reference
derived
Learn more about this trial
The Natural History of Community-Associated MRSA Infections and Decolonization Strategies
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