MRSA Colonization and Control in the Dallas County Jail

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00785200
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : June 12, 2013
University of Texas Southwestern Medical Center
Sage Products, Inc.
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Methicillin-resistant Staphylococcus Aureus Skin Diseases, Infectious Soft Tissue Infections Other: Chlorhexidine Other: Water Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: MRSA Colonization and Control in the Dallas County Jail
Study Start Date : January 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : February 2010

Arm Intervention/treatment
Experimental: 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.
Other: Chlorhexidine
Chlorhexidine-soaked disposable cloths will be distributed each Monday, Wednesday, and Friday to each enrolled detainee for a 6-month period.

Placebo Comparator: 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.
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.

No Intervention: 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.

Primary Outcome Measures :
  1. Average prevalence of MRSA hand or nasal colonization in study tanks (i.e., 24-60-person detention divisions) receiving CHG cloths vs. usual care [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Average incidence of skin and soft tissue infections requiring incision and drainage per tank in a 6 month period, comparing group of study tanks receiving CHG-soaked washcloths to those receiving usual care. [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Admission to a participating tank in the jail

Exclusion Criteria:

  • History of hypersensitivity reaction to chlorhexidine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00785200

United States, Texas
The Dallas County Jail
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Chicago
University of Texas Southwestern Medical Center
Sage Products, Inc.
Principal Investigator: Robert S Daum, MD University of Chicago

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Chicago Identifier: NCT00785200     History of Changes
Other Study ID Numbers: 14633A (R01 CI000373-03)
R01CI000373-03 ( U.S. NIH Grant/Contract )
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: February 2010

Keywords provided by University of Chicago:
Methicillin-resistant Staphylococcus aureus
Asymptomatic colonization
Asymptomatic colonization, MRSA
Skin and soft tissue infections

Additional relevant MeSH terms:
Skin Diseases
Staphylococcal Infections
Soft Tissue Infections
Communicable Diseases
Skin Diseases, Infectious
Gram-Positive Bacterial Infections
Bacterial Infections
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Dermatologic Agents