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

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00254527
First received: November 14, 2005
Last updated: April 30, 2007
Last verified: November 2005
  Purpose

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.

Condition
Methicillin Resistance
Staphylococcus Aureus

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Colonization, Infection, and Molecular Typing of Methicillin-Resistant Staphylococcus Aureus (MRSA) in Children.

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Enrollment: 477
Study Start Date: January 2005
Study Completion Date: April 2007
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

Ages Eligible for Study:   3 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  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: NCT00254527

Locations
United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Emily A Thorell, MD Children's Mercy Hospital Kansas City
  More Information

Publications:
Wadlvogel FA. Staphylococcus aureus. In: Mandell GL, Bennett JE, Dolin R, editors. Principles and Practice of Infectious Diseases. 5th ed. Philadelphia: Churchill Livingstone, 2000. p.2072-3
Kirby WMM. Extraction of a Highly Potent Penicillin Inactivator from Penicillin Resistant Staphylococci. Science 1944;99:452-3
CDC. Four pediatric deaths from community-acquired methicillin-resistant Staphylococcus aureus—Minnesota and North Dakota, 1997-1999. MMWR Morb Mortal Wkly Rep 1999;48:707-10.
Thorell E, Jackson MA, Bratcher D, Swanson DS, Selvarangan R. Antimicrobial Resistance of Staphylococcus aureus from Kansas City Children: What is the Appropriate Current Therapy for Pediatric Staphylococcal Infections? 42nd Annual Meeting of Infectious Diseases Society of America, Boston, Sept 30- Oct 3, 2004

ClinicalTrials.gov Identifier: NCT00254527     History of Changes
Other Study ID Numbers: IRB# 04 11-135E
Study First Received: November 14, 2005
Last Updated: April 30, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Mercy Hospital Kansas City:
Methicillin Resistant Staphylococcus aureus
Children
Colonization
Risk Factor

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Methicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014