Prevention of Recurrent Infections Caused by Community Acquired Staphylococcus Aureus (CA-SA) in Children

Not Applicable

Completed

Conditions: Community-Acquired Staphylococcus Aureus

Interventions: Procedure: Routine Measures Group
Procedure: Bleach Bath Group (Bleach plus routine measures)

Registration Number: NCT00901316

Lead Sponsor: Baylor College of Medicine

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 987

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine Measures	Routine Measures Group	-
Bleach Baths	Bleach Bath Group (Bleach plus routine measures)	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures