Clinical trial NCT00901316: Prevention of Recurrent Infections Caused by Community Acquired Staphylococcus Aureus (CA-SA) in Children
Official title: Prevention of Recurrent Infections Caused by Community-Acquired Staphylococcus in Children 3 Months to 18 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-Acquired Staphylococcus Aureus
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
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2009-05-13
Enrollment: 987
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medically Attended Skin and Soft Tissue Infections (MA-SSI)
timeFrame: From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Sheldon L Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References: