Colonization, Infection, and Molecular Typing of Methicillin-Resistant Staphylococcus Aureus (MRSA) in Children.

April 30, 2007 updated by: Children's Mercy Hospital Kansas City

The intent of this study is to:

  1. Define the prevalence of MRSA carriage in the pediatric population in Kansas City.
  2. Systematically define patient risk factors for MRSA carriage and infection.
  3. Characterize the unique genetic characteristics of MRSA strains, both community acquired (CA) and healthcare associated (HCA) that are present in the different pediatric populations.

Study Overview

Status

Completed

Conditions

Detailed Description

Staphylococcus aureus (SA) are responsible for both localized and invasive infections including carbuncles, cellulitis, lymph node abscess, and wound infections among others. SA is a ubiquitous environmental organism that colonizes 30-50% adults and more than 50% of children with underlying skin disorders. Hematogenous seeding can result in fulminant infection, and sites as diverse as bone, joint, lung, muscle, pericardium, endocardium, and other vascular structures can be involved. Factors which are known to increase the risk for colonization include the presence of underlying skin disorders and history of frequent needle use which occur in the setting of diabetes, or hemodialysis. Health care workers have traditionally been noted to have higher carriage rates.

MRSA strains emerged in the last two decades in the US and similarities to the evolution of penicillin resistant S. aureus were noted with colonization and infection in the hospital based setting noted first. Again, risk factors for MRSA colonization or infection in the hospital were noted to include prior antibiotic exposure, admission to an intensive care unit, surgery, and exposure to an MRSA-colonized patient. Emergence of CA-MRSA strains has been noted in the last decade having resistance to methicillin and erythromycin but susceptibility to clindamycin. These strains have challenged the practitioner's approach to the treatment of common skin and soft tissue infections as well as the management of invasive disease. The importance of such strains was underscored by the 1999 report detailing the deaths of 4 US children with invasive MRSA infection, none of whom had identifiable MRSA risk factors. Pulsed field typing of the isolates confirmed that these community strains were distinct from nosocomial strains isolated from patients in local hospitals.

This study seeks to more clearly define the prevalence of MRSA carriage; better identify risk factors through personal interview; and further identify resistance patterns and molecular strains. This data will guide physicians at Children's Mercy and in the community at large in choosing the best treatment option for children with MRSA infections.

The absence of traditional risk factors for MRSA infection has been noted in children with CA infections. Many studies that describe risk factors in MRSA patients do so by retrospective review of the medical record. Misclassification of patients may occur as physicians do not routinely document the presence or absence of such risk factors, particularly among household contacts.

This study will look at nasal colonization for 500 children in the Kansas City area to determine prevalence of MRSA colonization. During the study period, all invasive MRSA isolates will also be collected. Pulsed field typing will be done to determine whether the strains are community or healthcare associated and both groups will be compared.

Study Type

Observational

Enrollment (Actual)

477

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Colonization:

- Children ages 3 months to 12 years

Invasive:

- Invasive MRSA infection

Exclusion Criteria:

Colonization:

-None

Invasive:

-Those without invasive MRSA infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Other

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Emily A Thorell, MD, Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

November 14, 2005

First Submitted That Met QC Criteria

November 14, 2005

First Posted (Estimate)

November 16, 2005

Study Record Updates

Last Update Posted (Estimate)

May 2, 2007

Last Update Submitted That Met QC Criteria

April 30, 2007

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 04 11-135E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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