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

NCT ID: NCT00966446

Last Updated: 2019-07-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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

Conditions

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MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Unsupervised Decolonization

Intervention Type DRUG

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 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.

Group Type EXPERIMENTAL

Supervised Decolonization

Intervention Type DRUG

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.

No Intervention

Households do not undergo active MRSA decolonization protocol

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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Experimental: Unsupervised Decolonization Experimental: Supervised Decolonization

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pennsylvania Department of Health

OTHER_GOV

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ebbing Lautenbach, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Shahbazian JH, Hahn PD, Ludwig S, Ferguson J, Baron P, Christ A, Spicer K, Tolomeo P, Torrie AM, Bilker WB, Cluzet VC, Hu B, Julian K, Nachamkin I, Rankin SC, Morris DO, Lautenbach E, Davis MF. Multidrug and Mupirocin Resistance in Environmental Methicillin-Resistant Staphylococcus aureus (MRSA) Isolates from Homes of People Diagnosed with Community-Onset MRSA Infection. Appl Environ Microbiol. 2017 Oct 31;83(22):e01369-17. doi: 10.1128/AEM.01369-17. Print 2017 Nov 15.

Reference Type DERIVED
PMID: 28939607 (View on PubMed)

Cluzet VC, Gerber JS, Metlay JP, Nachamkin I, Zaoutis TE, Davis MF, Julian KG, Linkin DR, Coffin SE, Margolis DJ, Hollander JE, Bilker WB, Han X, Mistry RD, Gavin LJ, Tolomeo P, Wise JA, Wheeler MK, Hu B, Fishman NO, Royer D, Lautenbach E; CDC Prevention Epicenters Program. The Effect of Total Household Decolonization on Clearance of Colonization With Methicillin-Resistant Staphylococcus aureus. Infect Control Hosp Epidemiol. 2016 Oct;37(10):1226-33. doi: 10.1017/ice.2016.138. Epub 2016 Jul 28.

Reference Type DERIVED
PMID: 27465112 (View on PubMed)

Other Identifiers

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809899

Identifier Type: -

Identifier Source: org_study_id

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