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

MRSA - Methicillin Resistant Staphylococcus Aureus Infection Clinical Trial

Official title:

Epidemiology and Prevention of MRSA Transmission in the Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966446
• Other study ID #: 809899
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: December 2014

Study information

• Verified date: July 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• MRSA - Methicillin Resistant Staphylococcus Aureus Infection
• Staphylococcal Infections

Intervention

Drug:
• Unsupervised Decolonization
Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril 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. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member.
• Supervised Decolonization
Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril 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. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member. In addition, households are contacted by study stuff via phone or text messages to ensure compliance, to provide reminders to household members to perform the decolonization protocol as well as to answer any question/concerns household members may have.

Locations

Country	Name	City	State
United States	Hershey Medical Center	Hershey	Pennsylvania
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	Children's Hospital of Philadelphia, Milton S. Hershey Medical Center, Pennsylvania Department of Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent Infection	Confirmed new MRSA infections	Within 6 months
Primary	First Two Consecutive Sampling Periods Completed	Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis	Within 2 months
Secondary	Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization	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.	Within 6 months