MRSA Colonization and Control in the Dallas County Jail

NCT00785200 | Completed

• 2 other identifiers: 14633A (R01 CI000373-03)R01CI000373-03
• Study Type: interventional
• Target: 4,194
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

MRSA; Methicillin-resistant Staphylococcus aureus; Chlorhexidine; Asymptomatic colonization; Asymptomatic colonization, MRSA; Skin and soft tissue infections

Outcome Measures

Primary Outcomes (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

  6 months

Secondary Outcomes (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.

  18 months

Study Arms (3)

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.

Other: Chlorhexidine

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.

Other: Water

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.

Interventions

Chlorhexidine OTHER

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

Chlorhexidine

Water 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.

Water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admission to a participating tank in the jail

You may not qualify if:

• History of hypersensitivity reaction to chlorhexidine

Sponsors & Collaborators

• University of Chicago: lead
• University of Texas Southwestern Medical Center: collaborator
• Sage Products, Inc.: collaborator

Study Sites (1)

The Dallas County Jail

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 25419768 DERIVED

MeSH Terms

Conditions

Skin Diseases, Infectious; Soft Tissue Infections; Asymptomatic Infections

Interventions

Chlorhexidine; Water

Condition Hierarchy (Ancestors)

Infections; Skin Diseases; Skin and Connective Tissue Diseases; Asymptomatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Robert S Daum, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 5, 2008
• Study Start: January 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: February 1, 2010
• Last Updated: June 12, 2013

Record last verified: 2010-02

Locations

US (1)