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

• ClinicalTrials.gov Identifier: NCT00901316
• Recruitment Status: Completed
• First Posted: May 13, 2009
• Results First Posted: November 6, 2016
• Last Update Posted: November 6, 2016
• Sponsor: Baylor College of Medicine
• Information provided by (Responsible Party): Sheldon Kaplan, Baylor College of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Community-Acquired Staphylococcus Aureus	Procedure: Routine Measures Group; Procedure: Bleach Bath Group (Bleach plus routine measures)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 987 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prevention of Recurrent Infections Caused by Community-Acquired Staphylococcus in Children 3 Months to 18 Years
• Study Start Date: June 2009
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: January 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Routine Measures	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. 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.; Other Name: Prevention of Infections Caused by CA-SA in Children.
Experimental: Bleach Baths	Procedure: Bleach Bath Group (Bleach plus 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 Name: Clorox Baths

Outcome Measures

Primary Outcome Measures :

1. Medically Attended Skin and Soft Tissue Infections (MA-SSI) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 3 Months to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Texas

Baylor College of Medicine

Houston, Texas, United States, 77030

Texas Children's Hospital

Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

• Principal Investigator: Sheldon L Kaplan, MD; Baylor College of Medicine

More Information

Additional Information:

NCT00179959 

• Responsible Party: Sheldon Kaplan, Professor of Pediatrics, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT00901316
• Other Study ID Numbers: Thrasher21631
• First Posted: May 13, 2009
• Results First Posted: November 6, 2016
• Last Update Posted: November 6, 2016
• Last Verified: September 2016

Keywords provided by Sheldon Kaplan, Baylor College of Medicine:

Skin and Soft Tissue Infections; Abscesses; Boils; Clorox Baths; Colonization; Staph; MRSA; MSSA; Recurrent Infections; Prevention CA-SA Infections; Community-Acquired Staphylococcus in Children

Additional relevant MeSH terms:

Infections; Reinfection; Disease Attributes; Pathologic Processes; Recurrence