Methicillin-resistant Staphylococcus AureusNCT00785200
MRSA Colonization and Control in the Dallas County Jail
A study testing Chlorhexidine and Water in people with Methicillin-resistant Staphylococcus Aureus and Skin Diseases, Infectious, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Methicillin-resistant Staphylococcus Aureus, Skin Diseases, Infectious, Soft Tissue Infections
- What is being tested?
- Chlorhexidine and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,194 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Admission to a participating tank in the jail
Who cannot join
- History of hypersensitivity reaction to chlorhexidine
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Chlorhexidine, Water
- Keywords
- MRSA, Methicillin-resistant Staphylococcus aureus, Chlorhexidine, Asymptomatic colonization, Asymptomatic colonization, MRSA, Skin and soft tissue infections
- Medical subject headings
- Skin Diseases, Infectious, Soft Tissue Infections, Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineOther
Chlorhexidine-soaked disposable cloths will be distributed each Monday, Wednesday, and Friday to each enrolled detainee for a 6-month period.
WaterOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average prevalence of MRSA hand or nasal colonization in study tanks (i.e., 24-60-person detention divisions) receiving CHG cloths vs. usual care
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionJul 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Methicillin-resistant Staphylococcus AureusStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Sage Products, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert S Daum, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00785200
- Sponsor's protocol ID
- 14633A (R01 CI000373-03)
- Other IDs
- R01CI000373-03
- Status last verified
- Feb 2010
- First submitted
- 3 Nov 2008
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25419768
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRSA Colonization and Control in the Dallas County Jail
- ClinicalTrials.gov ID
- NCT00785200
- Acronym / sponsor ID
- 14633A (R01 CI000373-03)
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,194 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, Sage Products, Inc.
- Study start
- Jan 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 5 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Experimental | Other: ChlorhexidineApproximately 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. |
| Water | Placebo comparator | Other: WaterApproximately 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admission to a participating tank in the jail
Key exclusion criteria (1 listed)
- History of hypersensitivity reaction to chlorhexidine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChlorhexidineChlorhexidine-soaked disposable cloths will be distributed each Monday, Wednesday, and Friday to each enrolled detainee for a 6-month period. | Other | Chlorhexidine |
| WaterWater-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. | Other | Water |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
- Derived from this study: PubMed 25419768David 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.
Related trials for Methicillin-resistant Staphylococcus Aureus
Not yet recruitingPhase 2
A Clinical Trial of Resistant Potato Starch for Gut MDRO Decolonization
Clostridium Infections, Methicillin-resistant Staphylococcus Aureus (MRSA)
RecruitingPhase 4
Trimethoprim-sulfamethoxazole vs. Clindamycin for the Treatment of Children With Invasive MRSA Infections
Methicillin Resistant Staphylococcus Aureus, Osteomyelitis Acute
Active, not recruitingObservational study
Comparative Analysis of Nemonoxacin and Other Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA) Antimicrobial Therapy in Patients With Complicated Skin and Soft Tissue Infections (cSSTI): a Retrospective Chart Review Study
Methicillin-susceptible S. Aureus (MSSA), Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Daum, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chlorhexidine and Water in people with Methicillin-resistant Staphylococcus Aureus and Skin Diseases, Infectious, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00785200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2013; AzTrials last refreshed its copy on 6 Nov 2026.