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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Texas Children's Hospital
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00901316
First received: May 11, 2009
Last updated: May 12, 2009
Last verified: May 2009
  Purpose

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 Intervention
Community-Acquired Staphylococcus Aureus
Procedure: Routine Measures Group
Procedure: Bleach Bath Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of Recurrent Infections Caused by Community-Acquired Staphylococcus in Children 3 Months to 18 Years

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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. [ Time Frame: 2011-2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: June 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Prevention of Infections Caused by CA-SA in Children.
Experimental: Bleach Baths Procedure: 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.
Other Name: Clorox Baths

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).

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.
  Eligibility

Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901316

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
Texas Children's Hospital
Investigators
Principal Investigator: Sheldon L Kaplan, MD Baylor College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Sheldon L. Kaplan / Principal Investigator, Texas Children's Hospital / Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00901316     History of Changes
Other Study ID Numbers: Thrasher21631
Study First Received: May 11, 2009
Last Updated: May 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by 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:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Sodium Hypochlorite
Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014