Staphylococcus Aureus Decolonization Study (SuDS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stephanie A. Fritz, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00731783
First received: August 7, 2008
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Household vs. Individual Approach to Decolonization of Community-acquired Methicillin-resistant Staphylococcus Aureus.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures [ Time Frame: 1 month after enrollment. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 month after enrollment. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 month after enrollment. ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 month after enrollment. ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 month after enrollment ] [ Designated as safety issue: No ]
    Recurrence of CA-MRSA Skin or Soft Tissue Infection

  • Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment. [ Time Frame: 3 month after enrollment ] [ Designated as safety issue: No ]
    Recurrence of CA-MRSA Skin or Soft Tissue Infection

  • Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment. [ Time Frame: 6 month after enrollment ] [ Designated as safety issue: No ]
    Recurrence of CA-MRSA Skin or Soft Tissue Infection

  • Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment. [ Time Frame: 12 month after enrollment ] [ Designated as safety issue: No ]
    Recurrence of CA-MRSA Skin or Soft Tissue Infection


Enrollment: 183
Study Start Date: July 2008
Study Completion Date: December 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Index patient only
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.
Other Name: Bactroban
Drug: 4% Chlorhexidine liquid soap
Bathe with liquid soap daily for 5 days.
Other Name: Hibiclens
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.
Active Comparator: Household
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.
Other Name: Bactroban
Drug: 4% Chlorhexidine liquid soap
Bathe with liquid soap daily for 5 days.
Other Name: Hibiclens
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. 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Fritz, MD Washington University School of Medicine
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephanie A. Fritz, Assistant Professor of Pediatrics, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00731783     History of Changes
Other Study ID Numbers: 3177 38145
Study First Received: August 7, 2008
Results First Received: March 2, 2011
Last Updated: April 23, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Communicable Diseases
Furunculosis
Infection
Skin Diseases, Infectious
Staphylococcal Skin Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Skin Diseases
Skin Diseases, Bacterial
Staphylococcal Infections
Chlorhexidine
Anti-Infective Agents
Anti-Infective Agents, Local
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014