Clinical Trial: Staphylococcus Aureus Decolonization Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Household vs. Individual Approach to Decolonization of Community-acquired Methicillin-resistant Staphylococcus Aureus.

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 Summary:

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
Sponsor: Washington University School of Medicine

Current Primary Outcome: Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures [ Time Frame: 1 month after enrollment. ]

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.


Original Primary Outcome: The Primary Outcome Measure Will be Eradication of S. Aureus Carriage 1 Month After Performing Decolonization Measures. [ Time Frame: 1 month after enrollment. ]

Current Secondary Outcome:

  • Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures [ Time Frame: 3 month after enrollment. ]
    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. ]
    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. ]
    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 ]
    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 ]
    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 ]
    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 ]
    Recurrence of CA-MRSA Skin or Soft Tissue Infection


Original Secondary Outcome:

  • Recurrence of CA-MRSA Skin or Soft Tissue Infection. [ Time Frame: 1, 3, 6, 9 and 12 months after enrollment. ]
  • Eradication of S. Aureus Carriage After Performing Decolonization Measures. [ Time Frame: 3, 6 and 12 months after enrollment ]
  • Time to Recolonization. [ Time Frame: 3, 6 and 12 months after enrollment. ]


Information By: Washington University School of Medicine

Dates:
Date Received: August 7, 2008
Date Started: July 2008
Date Completion:
Last Updated: April 23, 2012
Last Verified: April 2012