Prevention of Recurrent Infections Caused by Community Acquired Staphylococcus Aureus (CA-SA) in Children
Condition: Community-Acquired Staphylococcus Aureus
MeSH terms: Infections; Reinfection
Study type: Interventional

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.
    

Intervention name(s): Routine Measures Group; Bleach Bath Group (Bleach plus routine measures)
Intervention type(s): Procedure; Procedure
Intervention description(s): 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.; 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.
Other intervention name(s): Prevention of Infections Caused by CA-SA in Children.; Clorox Baths
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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