MRSA Colonization and Control in the Dallas County Jail

Methicillin-resistant Staphylococcus Aureus Clinical Trial

Official title:

MRSA Colonization and Control in the Dallas County Jail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00785200
• Other study ID #: 14633A (R01 CI000373-03)
• Secondary ID: R01CI000373-03
• Status: Completed
• Phase: N/A
• First received: November 3, 2008
• Last updated: June 11, 2013
• Start date: January 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4194
• Est. completion date: February 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission to a participating tank in the jail

Exclusion Criteria:

• History of hypersensitivity reaction to chlorhexidine

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Methicillin-resistant Staphylococcus Aureus
• Skin Diseases
• Skin Diseases, Infectious
• Soft Tissue Infections
• Staphylococcal Infections

Intervention

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

Locations

Country	Name	City	State
United States	The Dallas County Jail	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Chicago	Sage Products, Inc., University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average prevalence of MRSA hand or nasal colonization in study tanks (i.e., 24-60-person detention divisions) receiving CHG cloths vs. usual care		6 months	No
Secondary	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.		18 months	No