Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the natural history of community-associated Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate of recurrent infections in those colonized with S. aureus.
In addition, this study will evaluate the efficiency of commonly prescribed decolonization measures in patients presenting with S. aureus skin and soft tissue infections.
Infections with community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) range in severity from superficial skin abscesses to invasive soft tissue infections like cellulitis and pyomyositis. There has been a large increase in the number of patients presenting to our institution with CA-MRSA infections. Colonization with S. aureus (SA) may be linked to the development of infection but data on this phenomenon are limited. The recurrence rate for CA-MRSA soft tissue infections is unknown. A variety of decolonization strategies have been used for infection prophylaxis with varying results, primarily in patients undergoing hemodialysis or surgery. This study seeks to determine the recurrence rate of soft tissue infections among patients with CA-MRSA infections and to determine a reasonable and efficacious decolonization strategy to eradicate CA-MRSA from previously infected patients.
The proposed methods for decolonization will be tested in a randomized controlled trial with four intervention arms. The intervention arms are: (1) intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group"), (2) application of mupirocin in the nasal mucosa alone, (3) a combination of nasal application of mupirocin and chlorhexidine showers, and (4) a combination of nasal application of mupirocin and bathing in dilute bleach water. The "control" group as well as the three other arms will receive intensive hygiene education.
Decolonization with mupirocin ointment and chlorhexidine showers or dilute bleach baths in combination are likely to be more successful than either the application of nasal mupirocin ointment alone or hygiene measures alone. It is expected that these decolonization methods will result in a 50% relative reduction in MRSA colonization at 6 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Hygiene Education | Active Comparator | Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group") |
|
| 2: Hygiene education + mupirocin | Active Comparator | Application of mupirocin in the nasal mucosa alone |
|
| Education + mupirocin + chlorhexidine | Active Comparator | A combination of nasal application of mupirocin and chlorhexidine showers |
|
| 4: Education + mupirocin + bleach baths | Active Comparator | A combination of nasal application of mupirocin and bathing in dilute bleach water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mupirocin ointment | Drug | Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention | 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. Samples obtained by study team at follow-up visit. | 1 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit. | 1, 4 and 6 month follow-ups |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bernard C. Camins, MD, MSCR | Assistant Professor of Medicine, Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine | Principal Investigator |
| Gregory A. Storch, MD | Professor of Medicine and Molecular Microbiology, Chief of Division of Pediatric Infectious Diseases, Department of Medicine, Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States | ||
| St. Louis Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21828967 | Derived | Fritz SA, Camins BC, Eisenstein KA, Fritz JM, Epplin EK, Burnham CA, Dukes J, Storch GA. Effectiveness of measures to eradicate Staphylococcus aureus carriage in patients with community-associated skin and soft-tissue infections: a randomized trial. Infect Control Hosp Epidemiol. 2011 Sep;32(9):872-80. doi: 10.1086/661285. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Hygiene Education | Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group") |
| FG001 | Hygiene Education + Mupirocin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| One-Month Follow-Up |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Chlorhexidine showers | Genetic | Apply Clorhexidine wash to entire body once daily for 5 days. |
|
|
| Bleach baths (dilute) | Procedure | Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days. |
|
|
| Intensive education on personal hygiene | Behavioral | Repeat hygiene methods for 5 days. |
|
| Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention | 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. Samples obtained by study team at follow-up visit. | 4 month follow-up |
| St Louis |
| Missouri |
| 63110 |
| United States |
Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
| FG002 | Education + Mupirocin + Chlorhexidine | Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days. |
| FG003 | Education + Mupirocin + Bleach Baths | Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes). |
| COMPLETED |
|
| NOT COMPLETED |
|
| Four-Month Follow-Up |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Hygiene Education | Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group") |
| BG001 | Hygiene Education + Mupirocin | Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days |
| BG002 | Education + Mupirocin + Chlorhexidine | Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days. |
| BG003 | Education + Mupirocin + Bleach Baths | Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention | 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. Samples obtained by study team at follow-up visit. | Posted | Number | Participants | 1 month follow-up |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection | Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit. | Groups 1/4 have 1 more participant analyzed each than in participant flow module due to data collected by phone. They did not return to hospital for followup (colonization swabs were not obtained). Group 3 has 1 less participant analyzed than in participant flow module due to missing data point on followup survey. They were not able to be reached. | Posted | Number | Participants | 1, 4 and 6 month follow-ups |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention | 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. Samples obtained by study team at follow-up visit. | Posted | Number | Participants | 4 month follow-up |
|
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).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hygiene Education | Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group") | 0 | 72 | 4 | 72 | ||
| EG001 | Hygiene Education + Mupirocin | Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days | 0 | 72 | 1 | 72 | ||
| EG002 | Education + Mupirocin + Chlorhexidine | Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days. | 0 | 70 | 5 | 70 | ||
| EG003 | Education + Mupirocin + Bleach Baths | Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes). | 0 | 68 | 11 | 68 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry skin | Skin and subcutaneous tissue disorders |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Fritz | Washington University | 314-454-6050 | fritz_s@kids.wustl.edu |
| ID | Term |
|---|---|
| D000038 | Abscess |
| D005667 | Furunculosis |
| D013203 | Staphylococcal Infections |
| D013207 | Staphylococcal Skin Infections |
| ID | Term |
|---|---|
| D013492 | Suppuration |
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005393 | Fish Diseases |
| D000820 | Animal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016712 | Mupirocin |
| C010882 | chlorhexidine gluconate |
| D007201 | Indicator Dilution Techniques |
| D012973 | Sodium Hypochlorite |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D008919 | Investigative Techniques |
| D006997 | Hypochlorous Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D017670 | Sodium Compounds |
Not provided
Not provided
| Male |
|
| OG002 |
| Education + Mupirocin + Chlorhexidine |
A combination of nasal application of mupirocin and chlorhexidine showers Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days. Chlorhexidine showers: Apply Clorhexidine wash to entire body once daily for 5 days. Intensive education on personal hygiene: Repeat hygiene methods for 5 days. |
| OG003 | 4: Education + Mupirocin + Bleach Baths | A combination of nasal application of mupirocin and bathing in dilute bleach water Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days. Bleach baths (dilute): Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days. Intensive education on personal hygiene: Repeat hygiene methods for 5 days. |
|
|
| OG003 | 4: Education + Mupirocin + Bleach Baths | A combination of nasal application of mupirocin and bathing in dilute bleach water Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days. Bleach baths (dilute): Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days. Intensive education on personal hygiene: Repeat hygiene methods for 5 days. |
|
|