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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00731783 |
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 |
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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: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Household vs. Individual Approach to Decolonization of Community-Acquired Methicillin-Resistant Staphylococcus Aureus. |
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 |
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Index patient only: Active Comparator
Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.
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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:
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Household: Active Comparator
All members of the household (over the age of 6 months) will be asked to follow the study protocol.
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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:
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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.
Ages Eligible for Study: | 6 Months to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Screening:
Enrollment:
Exclusion Criteria:
United States, Missouri | |
St. Louis Children's Hospital | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Stephanie A Lutter, MD | Washington University School of Medicine |
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 |
Abscesses Furunculosis Staphylococcus aureus colonization Staphylococcal Skin Infections MRSA |
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 |
Anti-Infective Agents Anti-Infective Agents, Local Communicable Diseases Disinfectants |
Pathologic Processes Therapeutic Uses Infection Pharmacologic Actions |