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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Index patient only | Active Comparator | Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen. |
|
| Household | Active Comparator | All members of the household (over the age of 6 months) will be asked to follow the study protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% Mupirocin Ointment | Drug | Apply ointment to the anterior nares twice daily for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 month after enrollment. |
| Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures |
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Inclusion Criteria:
Screening:
Enrollment:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie A Fritz, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22198793 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Index Patient Only | Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days. |
| FG001 | Household | All members of the household (over the age of 6 months) will be asked to follow the study protocol, which includes application of 2% Mupirocin Ointment to the anterior nares twice daily for 5 days and washing with 4% Chlorhexidine liquid soap daily for 5 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| One Month Follow-Up Visit |
|
| ||||||||||||||||||
| Three Month Follow-Up Visit |
| |||||||||||||||||||
| Six Month Follow-Up Visit |
| |||||||||||||||||||
| 12 Month Follow-Up Visit |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Index Patient Only | Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen. |
| BG001 | Household | All members of the household (over the age of 6 months) will be asked to follow the study protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Modified intention to treat analysis | Posted | Number | Participants | 1 month after enrollment. |
|
Adverse events were collected by phone approximately 7-10 days following study enrollment. The intervention only lasted 5 days and thus all adverse events would have happened by this time.
There are more participants with data on adverse events than data on the primary outcome measure because some participants completed the follow-up phone call at 7-10 days (where adverse events were assessed) but failed to complete the 1 month follow-up visit (where primary outcome measure was assessed).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Index Patient Only | Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Skin | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie A. Fritz, M.D., M.S.C.I. | Washington University | 314-454-6050 | fritz_s@kids.wustl.edu |
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| ID | Term |
|---|---|
| D013207 | Staphylococcal Skin Infections |
| D000038 | Abscess |
| D005667 | Furunculosis |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D016712 | Mupirocin |
| C010882 | chlorhexidine gluconate |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
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| 4% Chlorhexidine liquid soap | Drug | Bathe with liquid soap daily for 5 days. |
|
|
| Hygiene protocol | Behavioral | Follow key hygiene tips indefinitely. Tips are:
|
|
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. |
| 6 month after enrollment. |
| 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. | 12 month after enrollment. |
| Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment. | Recurrence of CA-MRSA Skin or Soft Tissue Infection | 1 month after enrollment |
| Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment. | Recurrence of CA-MRSA Skin or Soft Tissue Infection | 3 month after enrollment |
| Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment. | Recurrence of CA-MRSA Skin or Soft Tissue Infection | 6 month after enrollment |
| Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment. | Recurrence of CA-MRSA Skin or Soft Tissue Infection | 12 month after enrollment |
| NOT COMPLETED |
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|
| NOT COMPLETED |
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| NOT COMPLETED |
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|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | 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. | Modified intention to treat analysis | Posted | Number | Participants | 3 month after enrollment. |
|
|
|
|
| Secondary | 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. | Modified intention to treat analysis | Posted | Number | Participants | 6 month after enrollment. |
|
|
|
|
| Secondary | 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. | Modified intention to treat analysis | Posted | Number | Participants | 12 month after enrollment. |
|
|
|
|
| Secondary | Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment. | Recurrence of CA-MRSA Skin or Soft Tissue Infection | Modified intention to treat analysis | Posted | Number | Participants | 1 month after enrollment |
|
|
|
|
| Secondary | Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment. | Recurrence of CA-MRSA Skin or Soft Tissue Infection | Modified intention to treat analysis | Posted | Number | Participants | 3 month after enrollment |
|
|
|
|
| Secondary | Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment. | Recurrence of CA-MRSA Skin or Soft Tissue Infection | Modified intention to treat analysis | Posted | Number | Participants | 6 month after enrollment |
|
|
|
|
| Secondary | Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment. | Recurrence of CA-MRSA Skin or Soft Tissue Infection | Modified intention to treat analysis | Posted | Number | Participants | 12 month after enrollment |
|
|
|
|
| 0 |
| 85 |
| 15 |
| 85 |
| EG001 | Household | All members of the household (over the age of 6 months) will be asked to follow the study protocol. | 0 | 77 | 17 | 77 |
| Rash | Skin and subcutaneous tissue disorders |
|
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| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013492 | Suppuration |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005393 | Fish Diseases |
| D000820 | Animal Diseases |
| D011714 |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |