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MRSA Colonization and Control in the Dallas County Jail

This study has been completed.
Sponsor:
Collaborators:
University of Texas Southwestern Medical Center
Sage Products, Inc.
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00785200
First received: November 3, 2008
Last updated: June 11, 2013
Last verified: February 2010
  Purpose

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 Intervention
Methicillin-resistant Staphylococcus Aureus
Skin Diseases, Infectious
Soft Tissue Infections
Other: Chlorhexidine
Other: Water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: MRSA Colonization and Control in the Dallas County Jail

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 4194
Study Start Date: January 2009
Study Completion Date: February 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Admission to a participating tank in the jail

Exclusion Criteria:

  • History of hypersensitivity reaction to chlorhexidine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785200

Locations
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.
Investigators
Principal Investigator: Robert S Daum, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00785200     History of Changes
Other Study ID Numbers: 14633A (R01 CI000373-03), R01 CI000373-03
Study First Received: November 3, 2008
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014