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Sponsors and Collaborators: |
University of Chicago University of Texas Southwestern Medical Center Sage Products, Inc. |
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Information provided by: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00785200 |
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 |
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Methicillin-Resistant Staphylococcus Aureus Skin Diseases, Infectious Soft Tissue Infections |
Other: Chlorhexidine Other: Water |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment |
Official Title: | MRSA Colonization and Control in the Dallas County Jail |
Estimated Enrollment: | 2915 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Chlorhexidine: Experimental
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.
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Other: Chlorhexidine
Chlorhexidine-soaked disposable cloths will be distributed each Monday, Wednesday, and Friday to each enrolled detainee for a 6-month period.
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Water: Placebo Comparator
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.
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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.
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Usual care: No Intervention
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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Z David, MD, PhD | 773-702-3904 | mdavid@medicine.bsd.uchicago.edu |
United States, Texas | |
The Dallas County Jail | |
Dallas, Texas, United States, 75390 |
Principal Investigator: | Robert S Daum, MD | University of Chicago |
Responsible Party: | The University of Chicago ( Dr. Robert S. Daum ) |
Study ID Numbers: | 14633A (R01 CI000373-03), R01 CI000373-03 |
Study First Received: | November 3, 2008 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00785200 |
Health Authority: | United States: Institutional Review Board |
MRSA Methicillin-resistant Staphylococcus aureus Chlorhexidine |
Asymptomatic colonization Asymptomatic colonization with methicillin-resistant Staphylococcus aureus Skin and soft tissue infections |
Bacterial Infections Staphylococcal Infections Gram-Positive Bacterial Infections Skin Diseases, Infectious Methicillin |
Chlorhexidine Soft Tissue Infections Skin Diseases Chlorhexidine gluconate |
Anti-Infective Agents Anti-Infective Agents, Local Communicable Diseases Disinfectants |
Therapeutic Uses Infection Dermatologic Agents Pharmacologic Actions |