Clinical trial NCT00785200: MRSA Colonization and Control in the Dallas County Jail
Official title: MRSA Colonization and Control in the Dallas County Jail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
name: Sage Products, Inc.
First posted: 2008-11-05
Enrollment: 4194
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Admission to a participating tank in the jail

Exclusion Criteria:

* History of hypersensitivity reaction to chlorhexidine

Primary outcomes:
measure: Average prevalence of MRSA hand or nasal colonization in study tanks (i.e., 24-60-person detention divisions) receiving CHG cloths vs. usual care
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 18 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: The Dallas County Jail
state: Texas
Study officials:
affiliation: University of Chicago
name: Robert S Daum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.