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Staphylococcus Aureus Decolonization Study (SuDS)

Primary Purpose

Staphylococcal Skin Infections, Abscesses, Furunculosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2% Mupirocin Ointment
4% Chlorhexidine liquid soap
Hygiene protocol
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Staphylococcal Skin Infections focused on measuring Abscesses, Furunculosis, Staphylococcus aureus colonization, Staphylococcal Skin Infections, MRSA

Eligibility Criteria

6 Months - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Louis Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Index patient only

Household

Arm Description

Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.

All members of the household (over the age of 6 months) will be asked to follow the study protocol.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.
Recurrence of CA-MRSA Skin or Soft Tissue Infection
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 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.
Recurrence of CA-MRSA Skin or Soft Tissue Infection
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.
Recurrence of CA-MRSA Skin or Soft Tissue Infection

Full Information

First Posted
August 7, 2008
Last Updated
April 23, 2012
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00731783
Brief Title
Staphylococcus Aureus Decolonization Study
Acronym
SuDS
Official Title
Household vs. Individual Approach to Decolonization of Community-acquired Methicillin-resistant Staphylococcus Aureus.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2010 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcal Skin Infections, Abscesses, Furunculosis, Staphylococcus Aureus, MRSA Infection
Keywords
Abscesses, Furunculosis, Staphylococcus aureus colonization, Staphylococcal Skin Infections, MRSA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Index patient only
Arm Type
Active Comparator
Arm Description
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
Arm Title
Household
Arm Type
Active Comparator
Arm Description
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Intervention Type
Drug
Intervention Name(s)
2% Mupirocin Ointment
Other Intervention Name(s)
Bactroban
Intervention Description
Apply ointment to the anterior nares twice daily for 5 days.
Intervention Type
Drug
Intervention Name(s)
4% Chlorhexidine liquid soap
Other Intervention Name(s)
Hibiclens
Intervention Description
Bathe with liquid soap daily for 5 days.
Intervention Type
Behavioral
Intervention Name(s)
Hygiene protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures
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.
Time Frame
1 month after enrollment.
Secondary Outcome Measure Information:
Title
Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures
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.
Time Frame
3 month after enrollment.
Title
Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures
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.
Time Frame
6 month after enrollment.
Title
Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures
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.
Time Frame
12 month after enrollment.
Title
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment.
Description
Recurrence of CA-MRSA Skin or Soft Tissue Infection
Time Frame
1 month after enrollment
Title
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment.
Description
Recurrence of CA-MRSA Skin or Soft Tissue Infection
Time Frame
3 month after enrollment
Title
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment.
Description
Recurrence of CA-MRSA Skin or Soft Tissue Infection
Time Frame
6 month after enrollment
Title
Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment.
Description
Recurrence of CA-MRSA Skin or Soft Tissue Infection
Time Frame
12 month after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie A Fritz, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
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
22198793
Citation
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.
Results Reference
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Staphylococcus Aureus Decolonization Study

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