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

Community-Acquired Staphylococcus Aureus Clinical Trial

Official title:

Prevention of Recurrent Infections Caused by Community-Acquired Staphylococcus in Children 3 Months to 18 Years

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00901316
• Other study ID #: Thrasher21631
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 11, 2009
• Last updated: May 12, 2009
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: May 2009
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Community-Acquired Staphylococcus Aureus

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Texas Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The reduction of 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.		2011-2012	Yes

External Links

•   NCT00179959