Epidemiology and Prevention of Methicillin Resistant Staphylococcus Aureus (MRSA) Transmission in the Community - Full Text View

Sponsor:	University of Pennsylvania
Collaborators:	Pennsylvania Department of Health Children's Hospital of Philadelphia Penn State University Lincoln University
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00966446

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 Infection/Colonization	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 ]

Estimated Enrollment:	1215
Study Start Date:	September 2009
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: No decolonization Households do not undergo active MRSA decolonization protocol	Drug: MRSA decolonization Households will undergo decolonization for MRSA with mupirocin and chlorhexidine
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:

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.
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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966446

Contacts

Contact: Pam Tolomeo, MPH

215-573-7763

tolomeop@mail.med.upenn.edu

Sponsors and Collaborators

University of Pennsylvania

Pennsylvania Department of Health

Children's Hospital of Philadelphia

Penn State University

Lincoln University

Investigators

Principal Investigator:

Ebbing Lautenbach, MD

University of Pennsylvania

More Information

No publications provided

Responsible Party:	Ebbing Lautenbach, MD, MPH, MSCE, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00966446 History of Changes
Other Study ID Numbers:	809899
Study First Received:	August 25, 2009
Last Updated:	August 26, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

MRSA; household; infection; colonization

Additional relevant MeSH terms:

Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on February 09, 2012