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

Not Applicable

Completed

• Conditions: MRSA - Methicillin Resistant Staphylococcus Aureus Infection
• Interventions: Drug: Supervised Decolonization; Drug: Unsupervised Decolonization

• Registration Number: NCT00966446
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

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

Study Timeline

• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Study Start: 2009-09
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Results First Submitted: 2015-12-01
• Results First Submitted QC: 2016-05-20
• Results First Posted: 2016-06-29
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised Decolonization	Supervised Decolonization	Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Study staff is in contact with household members during this intervention to ensure compliance.
Unsupervised Decolonization	Unsupervised Decolonization	Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided.

Primary Outcome Measures

Name	Time	Method
First Two Consecutive Sampling Periods Completed	Within 2 months	Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis
Recurrent Infection	Within 6 months	Confirmed new MRSA infections

Secondary Outcome Measures

Name	Time	Method
Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization	Within 6 months	Surveillance cultures negative for two consecutive sampling periods; date of clearance determined as midpoint between date of last positive surveillance culture and first negative surveillance culture.

Trial Locations

Locations (4)

Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States