Clinical trial NCT00254527: Colonization, Infection, and Molecular Typing of Methicillin-Resistant Staphylococcus Aureus (MRSA) in Children.
Official title: Colonization, Infection, and Molecular Typing of Methicillin-Resistant Staphylococcus Aureus (MRSA) in Children.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Methicillin Resistance
Staphylococcus Aureus
Keywords: Methicillin Resistant Staphylococcus aureus
Children
Colonization
Risk Factor
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2005-11-16
Enrollment: 477
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

Colonization:

- Children ages 3 months to 12 years

Invasive:

- Invasive MRSA infection

Exclusion Criteria:

Colonization:

-None

Invasive:

-Those without invasive MRSA infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Emily A Thorell, MD
role: PRINCIPAL_INVESTIGATOR
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