Epidemiology and Prevention of Methicillin Resistant Staphylococcus Aureus (MRSA) Transmission in the Community

This study has been completed.
Sponsor:
Collaborators:
Pennsylvania Department of Health
Children's Hospital of Philadelphia
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
Ebbing Lautenbach, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00966446
First received: August 25, 2009
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

The overall goal of this project is to elucidate the epidemiology of MRSA transmission in the community and test an intervention to prevent MRSA transmission in this setting.


Condition Intervention
MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Drug: MRSA decolonization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Epidemiology and Prevention of MRSA Transmission in the Community

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • New MRSA infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 972
Study Start Date: September 2009
Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No intervention
Households do not undergo active MRSA decolonization protocol
Experimental: Unsupervised Decolonization
Households undergo decolonization for MRSA without study supervision
Drug: MRSA decolonization
Households will undergo decolonization for MRSA with mupirocin and chlorhexidine
Experimental: Supervised Decolonization
Households undergo supervised decolonization for MRSA
Drug: MRSA decolonization
Households will undergo decolonization for MRSA with mupirocin and chlorhexidine

Detailed Description:

The overall goals of this project are to:

  1. to investigate the determinants of and evaluate potential interventions to reduce the spread of methicillin resistant Staphylococcus aureus (MRSA) infections in community settings in order to reduce the burden of this illness in the State of Pennsylvania. This objective has the following specific aims:

    • to identify host, microbiological and environmental risk factors for prolonged MRSA colonization, MRSA transmission and clinical MRSA infection among patients with MRSA skin and soft tissue infections (SSTIs) and their household contacts and to use stochastic agent-based modeling methods to quantify secondary spread of CO-MRSA in households.
    • to evaluate the impact of a decolonization intervention on MRSA infections in the household.
    • to identify immunological mechanisms underlying the ability of Streptococcus pneumoniae colonization to inhibit MRSA colonization, transmission and infection in order to identify potential future immunological targets for interventions.
  2. to foster multi-disciplinary and cross-institutional collaborations and develop the infrastructure for a Center of Excellence focused on antimicrobial drug resistance research, with the capacity for activities linking basic science, epidemiological and clinical intervention studies
  3. to enhance opportunities for basic and clinical research training for undergraduate and graduate students, particularly from underrepresented minorities, in order to increase the pipeline of future biomedical scientists and clinical investigators
  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All members of a household in which the index case is treated for a skin or soft tissue infection due to MRSA. All household members must agree to participate in order for the household to be enrolled

Exclusion Criteria:

  • Prior MRSA within past 6 months in the index case; age less than 6 months.
  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: NCT00966446

Locations
United States, Pennsylvania
Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Ebbing Lautenbach
Pennsylvania Department of Health
Children's Hospital of Philadelphia
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Ebbing Lautenbach, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Ebbing Lautenbach, Professor of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00966446     History of Changes
Other Study ID Numbers: 809899
Study First Received: August 25, 2009
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
MRSA; household; infection; colonization

Additional relevant MeSH terms:
Infection
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 16, 2014