Community-Acquired Staphylococcus Aureus Clinical Trial
Official title:
Prevention of Recurrent Infections Caused by Community-Acquired Staphylococcus in Children 3 Months to 18 Years
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.
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).
Secondary objectives are to test the hypotheses that the USA300 clone has a greater ability
to colonize skin or mucosal sites compared with other S. aureus clones and that recurrent S.
aureus infections in a child are more likely to be due to the same organism that caused the
initial infection than an isolate that is different from the initial isolate as determined
by molecular typing.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment