Community-Acquired Staphylococcus Aureus
Conditions
Keywords
Skin and Soft Tissue Infections, Abscesses, Boils, Clorox Baths, Colonization, Staph, MRSA, MSSA, Recurrent Infections, Prevention CA-SA Infections, Community-Acquired Staphylococcus in Children
Brief summary
The primary purpose of this study is to determine if adding bleach baths to routine ways for prevention of Staph infections is helpful. The amount added is a very weak amount. This would provide a relatively inexpensive method to help prevent recurrent skin infections caused by the Staph germ. The investigators will also be studying how often Staphylococcus aureus lives in the nose, throat, and groin area.
Detailed description
In many areas of the United States, methicillin-resistant Staphylococcus aureus is now an established community pathogen (CA-MRSA). At Texas Children's Hospital (TCH), about 75% of S. aureus isolates recovered from healthy children with infections are CA-MRSA and \> 90% of the CA-MRSA isolates are related to one clone, USA300, which also predominates throughout the U.S. From 8/05 to 7/06, 1400 children with CA-MRSA infection were seen at TCH; 60% were admitted to the hospital. Why the USA300 clone is so successful in spreading throughout the community is unclear, but it does harbor a unique set of genes not found in other S. aureus clones. The anterior nose in the most common area of the body colonized with S. aureus but it is not known if this is the primary site for colonization by CA-MRSA USA300 clone. Approximately 3.5% of children at TCH have a proven recurrence of S. aureus infection within 12 months; we believe this is a minimal estimate and that overall at least 10% of children have recurrences. There is no consensus on the best strategies for preventing recurrent S. aureus infections or spread of S. aureus among family members. At TCH, in addition to routine preventative measures, we often recommend for the patients to take a bath at least twice a week in water to which one teaspoon of household bleach (Clorox) has been added per gallon of water. Anecdotally this approach has decreased the recurrence rate of S. aureus infections, but this common strategy among dermatologists has not been formally evaluated and is thus controversial. Objectives The primary objective is to test the hypothesis that in children who have a community-acquired Staphylococcus aureus (CA-SA) infection, sodium hypochlorite baths (Clorox) are a safe and effective component of a prevention strategy that will reduce recurrent medically attended skin and soft tissue infection (MA-SSI). Specific Aims 1. Determine the recurrence rate (over a 12 month period) of medically attended skin and soft tissue infection visits in children initially evaluated in the TCH Emergency Center for whom a 3 month prevention strategy includes taking a bath twice a week in water to which sodium hypochlorite (Clorox) has been added and the recurrence rate in children for whom a similar prevention strategy has been recommended but without the bath component. 2. Determine the recurrence rate (over a 12 month period) of skin and soft tissue infection caused by CA-S. aureus in children for whom a 3-month prevention strategy includes taking a bath twice a week in water to which sodium hypochlorite (Clorox) has been added and the recurrence rate in children for whom a similar prevention strategy has been recommended but without the bath component. 3. Determine the + rates of S. aureus colonization of the anterior nares, pharynx, and groin for children being evaluated in the emergency center of Texas Children's Hospital (TCH) or admitted to TCH with suspected S. aureus infections.
Interventions
PROCEDURERoutine Measures Group
Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Please see supplemental material from the publication Randomized Trial of Bleach Baths plus Routine Hygienic Measures vs Routine Hygienic Measures Alone for Prevention of Recurrent Infections Clinical Infectious Diseases 2014;58:679-682 for the details regarding routine measures.
PROCEDUREBleach Bath Group (Bleach plus routine measures)
Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths. Please see supplemental material from the publication Randomized Trial of Bleach Baths plus Routine Hygienic Measures vs Routine Hygienic Measures Alone for Prevention of Recurrent Infections Clinical Infectious Diseases 2014;58:679-682 for the details regarding instructions for bleach baths.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Otherwise healthy children 3 months to 18 years seen in the emergency center of Texas Children's Hospital with suspected CA-S. aureus infections * Have a lesion which can be cultured (abscess or cellulitis with drainage, invasive infections) * Can be evaluated and treated in the emergency center and be followed as outpatients * Can be admitted to the hospital
Exclusion criteria
* Children less than 3 months old or greater than 18 years * Immune deficiency or underlying condition other than reactive airway disease or simple eczema which is not being followed by a dermatologist * Patient has a history of 2 or more previous skin or soft tissue infections * Children with one previous episode whose family may have already employed the sodium hypochlorite baths * Families without a bathtub or running water * Families without a phone or primary care physician * Families unable or unwilling to comply with the prevention measures * Hypersensitivity to sodium hypochlorite
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medically Attended Skin and Soft Tissue Infections (MA-SSI) | From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first. | Medically attended skin and soft tissue infections (MA-SSI) which is defined as a skin or soft tissue infection that has been evaluated and treated by a medical professional in an office, clinic, urgent care or emergency center setting. |
Countries
United States
Participant flow
Recruitment details
Children with probable community-associated Staphylococcus aureus skin and soft tissue or invasive infections were randomized to routine daily hygienic measures with or without bleach baths twice a week for 3 months.
Participants by arm
| Arm | Count |
|---|---|
| Routine Measures Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. | 492 |
| Bleach Baths Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths. | 495 |
| Total | 987 |
Baseline characteristics
| Characteristic | Total | Routine Measures | Bleach Baths |
|---|---|---|---|
| Age, Categorical <=18 years | 987 Participants | 492 Participants | 495 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1.85 years | 1.92 years | 1.8 years |
| Region of Enrollment United States | 987 participants | 492 participants | 495 participants |
| Sex: Female, Male Female | 529 Participants | 253 Participants | 276 Participants |
| Sex: Female, Male Male | 458 Participants | 239 Participants | 219 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 492 | 1 / 495 |
| serious Total, serious adverse events | 0 / 492 | 0 / 495 |
Outcome results
Primary
Medically Attended Skin and Soft Tissue Infections (MA-SSI)
Medically attended skin and soft tissue infections (MA-SSI) which is defined as a skin or soft tissue infection that has been evaluated and treated by a medical professional in an office, clinic, urgent care or emergency center setting.
Time frame: From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Routine Measures | Medically Attended Skin and Soft Tissue Infections (MA-SSI) | 20.9 percentage of partipants |
| Bleach Baths | Medically Attended Skin and Soft Tissue Infections (MA-SSI) | 17 percentage of partipants |