MRSA Colonization and Control in the Dallas County Jail

NCT ID: NCT00785200

Last Updated: 2013-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-02-28

Brief Summary

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The goal of this 3-year project is to control the spread of community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) in the Dallas County Jail. CA-MRSA is a bacterium spreading rapidly through healthy populations and becoming an epidemic in many regions of the U.S. Many people in the community are asymptomatically colonized by MRSA. There have been outbreaks of MRSA infections at prisons and jails. We will study the spread of MRSA in the jail to better understand how the bacteria are transmitted from person to person there and how we can prevent their transmission. All detainees asked to participate must give informed consent to do so; their privacy will be carefully protected. Detainees with a history of allergy to CHG will be excluded. Seventeen objects in the jail will be sampled for contamination with MRSA. Bacteria will be collected from all cultures obtained from patients with bacterial skin infections for 18 months in a part of the jail in order to determine how frequently these infections are caused by MRSA relative to other bacteria. A group of about 1500 adult detainees will be tested for colonization with MRSA in order to determine how commonly detainees carry the bacterium. A cluster-randomized 6-month study will be undertaken among these detainees and those who take their places when they leave the jail to determine if chlorhexidine (CHG)-containing disposable wash cloths for skin cleaning can decrease the prevalence of MRSA skin or nose colonization. Detainees receiving CHG cloths (about 500 detainees) will be compared to detainees receiving water-soaked cloths for skin cleaning (about 500 detainees) or no intervention (about 500 detainees). The primary outcome will be a difference in average colonization prevalence in detention tanks, which are discrete detention units housing detainees, comparing the usual care to the CHG-exposed tanks after 6 months of CHG cloth use. A secondary outcome will be a decrease in skin infections from any cause in the tanks receiving CHG compared with usual care. All of the MRSA isolates and a sample of the S. aureus isolates susceptible to methicillin from specimens colonizing or infecting detainees, as well as those contaminating surfaces and objects in the jail will be tested genetically in order to determine which strains of MRSA are present in the jail. This study may identify ways to stop the spread of MRSA among people in jails and prisons, as well as other places.

Detailed Description

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Conditions

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Methicillin-resistant Staphylococcus Aureus Skin Diseases, Infectious Soft Tissue Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Chlorhexidine

Approximately 500 detainees housed in approximately 23 detention tanks will be enrolled and receive 2% chlorhexidine-soaked disposable wash cloths (Sage Products, Inc.) to clean their skin on Mondays, Wednesdays, and Fridays for 6 months. Newly arrived detainees in the tanks will be offered enrollment in the study on a biweekly schedule.

Group Type EXPERIMENTAL

Chlorhexidine

Intervention Type OTHER

Chlorhexidine-soaked disposable cloths will be distributed each Monday, Wednesday, and Friday to each enrolled detainee for a 6-month period.

Water

Approximately 500 detainees in approximately 23 detention tanks will receive water-soaked wash cloths to clean their skin each Monday, Wednesday, and Friday for a 6-month period. If detainees newly arrive to these study tanks, they will be offered enrollment on a biweekly schedule.

Group Type PLACEBO_COMPARATOR

Water

Intervention Type OTHER

Water-soaked disposable wash cloths identical in appearance to the CHG cloths will be distributed to enrolled detainees on every Monday, Wednesday, and Friday for a 6-month period.

Usual care

Approximately 500 detainees in approximately 23 detention tanks will be enrolled. These detainees will not receive any intervention. They will be followed for 6 months, and newly arrived detainees will be offered enrollment on a biweekly schedule.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Chlorhexidine

Chlorhexidine-soaked disposable cloths will be distributed each Monday, Wednesday, and Friday to each enrolled detainee for a 6-month period.

Intervention Type OTHER

Water

Water-soaked disposable wash cloths identical in appearance to the CHG cloths will be distributed to enrolled detainees on every Monday, Wednesday, and Friday for a 6-month period.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Admission to a participating tank in the jail

Exclusion Criteria

* History of hypersensitivity reaction to chlorhexidine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role collaborator

Sage Products, Inc.

INDUSTRY

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert S Daum, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The Dallas County Jail

Dallas, Texas, United States

Site Status

Countries

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United States

References

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David MZ, Siegel JD, Henderson J, Leos G, Lo K, Iwuora J, Porsa E, Schumm LP, Boyle-Vavra S, Daum RS. A randomized, controlled trial of chlorhexidine-soaked cloths to reduce methicillin-resistant and methicillin-susceptible Staphylococcus aureus carriage prevalence in an urban jail. Infect Control Hosp Epidemiol. 2014 Dec;35(12):1466-73. doi: 10.1086/678606.

Reference Type DERIVED
PMID: 25419768 (View on PubMed)

Other Identifiers

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R01CI000373-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14633A (R01 CI000373-03)

Identifier Type: -

Identifier Source: org_study_id

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