NCT00966446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

June 29, 2016

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

5 years

First QC Date

August 25, 2009

Results QC Date

December 1, 2015

Last Update Submit

July 1, 2019

Conditions

MRSA - Methicillin Resistant Staphylococcus Aureus Infection

Keywords

MRSA; household; infection; colonization

Outcome Measures

Primary Outcomes (2)

  • Recurrent Infection

    Confirmed new MRSA infections

    Within 6 months

  • 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 Outcomes (1)

  • Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization

    Within 6 months

Study Arms (3)

Unsupervised Decolonization

EXPERIMENTAL

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.

Drug: Unsupervised Decolonization

Supervised Decolonization

EXPERIMENTAL

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.

Drug: Supervised Decolonization

No Intervention

NO INTERVENTION

Households do not undergo active MRSA decolonization protocol

Interventions

Unsupervised DecolonizationDRUG

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.

Also known as: Experimental: Unsupervised Decolonization
Unsupervised Decolonization
Supervised DecolonizationDRUG

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.

Also known as: Experimental: Supervised Decolonization
Supervised Decolonization

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

    PMID: 28939607DERIVED

  • 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.

    PMID: 27465112DERIVED

MeSH Terms

Conditions

Infections

Results Point of Contact

Title
Ebbing Lautenbach, MD, MPH, MSCE
Organization
Perelman School of Medicine, University of Pennsylvania
ebbing@mail.med.upenn.edu
215-898-6977

Study Officials

  • Ebbing Lautenbach, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 27, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2014

Study Completion

December 1, 2014

Last Updated

July 5, 2019

Results First Posted

June 29, 2016

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(4)