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Staphylococcus Aureus Decolonization Study (SuDS)
This study is enrolling participants by invitation only.
Sponsored by: Washington University School of Medicine
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00731783
  Purpose

The purpose of this study is to determine whether measures to eliminate the Staph germ from the skin (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. We hypothesize that there will be a greater number of households who are successful in eradicating when all members of the household participate than households where only the index patient is treated.


Condition Intervention
Staphylococcal Skin Infections
Abscesses
Furunculosis
Staphylococcus Aureus
MRSA Infection
Drug: 2% Mupirocin Ointment
Drug: 4% Chlorhexidine liquid soap
Behavioral: Hygiene protocol

MedlinePlus related topics: Germs and Hygiene Staphylococcal Infections
Drug Information available for: Chlorhexidine Chlorhexidine digluconate Ethanol Methicillin Mupirocin Mupirocin calcium Methicillin sodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Household vs. Individual Approach to Decolonization of Community-Acquired Methicillin-Resistant Staphylococcus Aureus.

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The primary outcome measure will be eradication of S. aureus carriage 1 month after performing decolonization measures. [ Time Frame: 1 month after enrollment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence of CA-MRSA skin or soft tissue infection. [ Time Frame: 1, 3, 6, 9 and 12 months after enrollment. ] [ Designated as safety issue: No ]
  • Eradication of S. aureus carriage after performing decolonization measures. [ Time Frame: 3, 6 and 12 months after enrollment ] [ Designated as safety issue: No ]
  • Time to recolonization. [ Time Frame: 3, 6 and 12 months after enrollment. ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: July 2008
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Index patient only: Active Comparator
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
Drug: 2% Mupirocin Ointment
Apply ointment to the anterior nares twice daily for 5 days.
Drug: 4% Chlorhexidine liquid soap
Bathe with liquid soap daily for 5 days.
Behavioral: Hygiene protocol

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.
Household: Active Comparator
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
Drug: 2% Mupirocin Ointment
Apply ointment to the anterior nares twice daily for 5 days.
Drug: 4% Chlorhexidine liquid soap
Bathe with liquid soap daily for 5 days.
Behavioral: Hygiene protocol

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.

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. We 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. We 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.

  Eligibility

Ages Eligible for Study:   6 Months to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731783

Locations
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Stephanie A Lutter, MD Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine ( Stephanie A. Lutter, MD )
Study ID Numbers: 3177 38145
Study First Received: August 7, 2008
Last Updated: August 7, 2008
ClinicalTrials.gov Identifier: NCT00731783  
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Abscesses
Furunculosis
Staphylococcus aureus colonization
Staphylococcal Skin Infections
MRSA

Study placed in the following topic categories:
Bacterial Infections
Mupirocin
Chlorhexidine
Skin Diseases
Furunculosis
Staphylococcal Skin Infections
Inflammation
Staphylococcal Infections
Skin Diseases, Infectious
Gram-Positive Bacterial Infections
Methicillin
Chlorhexidine gluconate
Abscess
Skin Diseases, Bacterial
Suppuration
Ethanol

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-Infective Agents, Local
Communicable Diseases
Disinfectants
Pathologic Processes
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009