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

Primary Purpose

Community-Acquired Staphylococcus Aureus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Routine Measures Group
Bleach Bath Group (Bleach plus routine measures)
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Community-Acquired Staphylococcus Aureus focused on measuring Skin and Soft Tissue Infections, Abscesses, Boils, Clorox Baths, Colonization, Staph, MRSA, MSSA, Recurrent Infections, Prevention CA-SA Infections, Community-Acquired Staphylococcus in Children

Eligibility Criteria

3 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baylor College of Medicine
  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Routine Measures

Bleach Baths

Arm Description

Outcomes

Primary Outcome Measures

Medically Attended Skin and Soft Tissue Infections (MA-SSI)
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.

Secondary Outcome Measures

Full Information

First Posted
May 11, 2009
Last Updated
September 19, 2016
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00901316
Brief Title
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

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
987 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine Measures
Arm Type
Experimental
Arm Title
Bleach Baths
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Routine Measures Group
Other Intervention Name(s)
Prevention of Infections Caused by CA-SA in Children.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bleach Bath Group (Bleach plus routine measures)
Other Intervention Name(s)
Clorox Baths
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medically Attended Skin and Soft Tissue Infections (MA-SSI)
Description
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.
Time Frame
From time of enrollment until the first MA-SSI or 12 months following enrollment, whichever came first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheldon L Kaplan, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.gov
Description
NCT00179959

Learn more about this trial

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

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