Bacterial InfectionsCA-MRSANCT00736554
What is the Prevalence of Methicillin-Resistant Staphylococcus Aureus in Skin and Soft Tissue Infections Presenting to the Emergency Departments of a Canadian Academic Health Care Center?
An observational study of Bacterial Infections and Gram-Positive Bacterial Infections, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Staphylococcus aureus is the most common bacteria responsible for skin, bone, and muscle infections. Recent studies from the United States have suggested that a type of this bacterium called methicillin resistant S. aureus (MRSA) has become dramatically more common, especially the community strain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Infections, Gram-Positive Bacterial Infections, Staphylococcal Infections
- How many people
- 152 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Nov 2008
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Selection of Participants: The objective of this prospective study is to determine the prevalence of MRSA and community acquired MRSA (CA-MRSA) in adult patients (>17 yrs old) presenting with skin or soft tissue infections to the emergency departments (EDs) of an academic health care setting in London, Ontario.
Who may be able to join
- All adult patients (> 17 years) whose chief complaint is consistent with skin or soft tissue infection (cellulitis, necrotizing soft tissue infection, wound infection, ulcer, septic bursitis, abscess including furuncle/carbuncle/superficial skin abscess, paronychia, hordeolum, pilonidal abscess, acute lymphadenitis, pilonidal cyst without abscess, and impetigo).
Who cannot join
- Patients will be excluded if they refuse to participate or written, informed consent is not obtained.
- Additionally, patients with Bartholin cysts, odontogenic infections and perianal abscesses will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of MRSA in Skin and Soft Tissue Infections in Two Ontario Emergency Departments.
Staphylococcus aureus is the most common bacteria responsible for skin, bone, and muscle infections. Recent studies from the United States have suggested that a type of this bacterium called methicillin resistant S. aureus (MRSA) has become dramatically more common, especially the community strain. However, Canadian data is still largely lacking. This study aims to determine the prevalence of community acquired (CA) MRSA among patients presenting with skin and soft tissue infections to the Urgent Care Center and Emergency Departments in London, Ontario. This will be determined by taking swabs at enrollment from patient's noses, throats, and sites of infection. Patients will be asked to complete a health questionnaire with the goal of identifying risk factors associated with CA-MRSA. Through follow-up swabs of participants' noses and throats at one and three months, the effects of treatment on patient's carrying MRSA will be determined. Results may be used to form guidelines for empirical S aureus treatment in the region, reducing possible morbidity and mortality from delayed or suboptimal treatment of CA-MRSA infections. Improved understanding of risk factors associated with MRSA infection in a Canadian setting, may also change the practice of physicians considering empiric antibiotic therapy for skin and soft tissue infections.
Read the detailed description
Objective \& Hypothesis: The objective of this prospective study is to determine the prevalence of MRSA and community acquired MRSA (CA-MRSA) in adult patients (>17yrs old) presenting with skin or soft tissue infections to the emergency departments (EDs) of an academic health care setting in London, Ontario. Secondary objectives will include the identification of demographic and clinical variables associated with MRSA, characterization of MRSA antimicrobial susceptibilities and genotypes, and determining the effects of treatment on MRSA colonization. We believe that the prevalence of MRSA and CA-MRSA in London, Ontario will be lower than rates recently published by academic hospitals from the United States. The hypothesis of the study is that patients presenting to the Emergency Departments in London, Ontario with skin and soft tissue infections will have a 10% prevalence of CA-MRSA, but certainly the prevalence may be much higher.
Purpose: Results from this research may be used as part of the guidelines for empirical S aureus treatment in the region, thus reducing possible morbidity and mortality from delayed or suboptimal treatment of CA-MRSA infections. This information, along with an improved understanding of risk factors associated with MRSA infection in a Canadian setting, has the potential to change the practice of physicians who are considering empiric antibiotic therapy for skin and soft tissue infections.
This study will focus on the epidemiology of patients with skin or soft tissue infections presenting to the adult emergency departments (EDs) at the London Health Sciences Centre (LHSC) and the Urgent Care Center at St. Joseph's Health Centre (SJHC). By using a comparison group of non CA-MRSA infections, the proportion of CA-MRSA with relation to the total MRSA and methicillin sensitive Staphylococcus aureus (MSSA) in the region will be investigated. The study will also investigate the risk factors in the CA-MRSA population including: demographics, housing history, contact with the health care system, past CA-MRSA infection, asymptomatic CA-MRSA colonization, colonization/infection of close contacts, involvement in contact sports/team sports, hygienic body shaving, chronic skin disorders, recurrent/recent antibiotic use, IV drug use, contact with incarcerated individuals, and chronic disease.
Through follow-up visits at one and three months involving nares and throat swabs of patients initially testing positive for MRSA the effects of treatment on MRSA colonization will be determined. Furthermore, a follow-up questionnaire will be administered to all patients at one month to determine complication rates for patients colonized with MRSA versus those not colonized.
The current recommendations for antibiotic treatment of unknown S. aureus infection are based on clinical judgment, and therefore an understanding of regional incidence and susceptibility of CA-MRSA are essential for empiric treatment. Through the microbiological analysis of the cases, laboratory parameters and antibiotic susceptibility of CA-MRSA presenting to LHSC will be established. As well, the clinical characteristics of these patients will be documented to aid clinicians in recognizing patients presenting with CA-MRSA.
Experimental Design: This study will be a prospective prevalence study involving adult patients (>17years old) with skin and soft-tissue infections presenting to the Emergency Departments of LHSC (University Hospital and Victoria Hospital) as well as to the Urgent Care of SJHC. These departments have a combined approximate total of 150,000 visits per year. The study has an expected enrollment of 152 patients from July 2008- July 2009. The study will continue until three months after the last patient has been enrolled so that follow-up nasal and throat swabs may be obtained, if applicable.
n = Z2 P (1-P) / d2 n = 1.962 * .10 (1- .10) / 0.052 n = 3.8416 * .10 * .90 / .0025 n = 138
While the investigators do not anticipate a problem with non-response or missing values, to take this into consideration, we will over-sample the above sample size by 10%. Therefore, we will recruit at least 152 patients to the study. Therefore, assuming 80% power, an estimated prevalence of 10%, and a precision level of 5%, 152 patients are needed to be 95% confident that the true proportion of MRSA in adult patients (>17yrs old) presenting with skin or soft tissue infections will be between 5% and 15%.
Written, informed consent will be obtained from all patients that meet the study inclusion criteria.
- Keywords
- Staphylococcus aureus, CA-MRSA, skin and soft tissue infections, resistance, emergency department
- Medical subject headings
- Bacterial Infections, Gram-Positive Bacterial Infections, Staphylococcal Infections, Soft Tissue Infections, Emergencies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Association of Emergency Physicians
- Investigators
- Christopher MB Fernandes, FRCP, FACEP, MD, Principal investigator, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736554
- Sponsor's protocol ID
- R-08-173
- Other IDs
- 13871E
- Acronym
- CA-MRSA
- Status last verified
- Jan 2011
- First submitted
- 14 Aug 2008
- Last updated
- 5 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of MRSA in Skin and Soft Tissue Infections in Two Ontario Emergency Departments.
- ClinicalTrials.gov ID
- NCT00736554
- Acronym / sponsor ID
- CA-MRSA / R-08-173
- Keywords
- Staphylococcus aureus, CA-MRSA, skin and soft tissue infections, resistance, emergency department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Association of Emergency Physicians
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 Aug 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.
Staphylococcus aureus is the most common bacteria responsible for skin, bone, and muscle infections. Recent studies from the United States have suggested that a type of this bacterium called methicillin resistant S. aureus (MRSA) has become dramatically more common, especially the community strain. However, Canadian data is still largely lacking. This study aims to determine the prevalence of community acquired (CA) MRSA among patients presenting with skin and soft tissue infections to the Urgent Care Center and Emergency Departments in London, Ontario. This will be determined by taking swabs at enrollment from patient's noses, throats, and sites of infection. Patients will be asked to complete a health questionnaire with the goal of identifying risk factors associated with CA-MRSA. Through follow-up swabs of participants' noses and throats at one and three months, the effects of treatment on patient's carrying MRSA will be determined. Results may be used to form guidelines for empirical S aureus treatment in the region, reducing possible morbidity and mortality from delayed or suboptimal treatment of CA-MRSA infections. Improved understanding of risk factors associated with MRSA infection in a Canadian setting, may also change the practice of physicians considering empiric antibiotic therapy for skin and soft tissue infections.
Detailed description
Objective \& Hypothesis: The objective of this prospective study is to determine the prevalence of MRSA and community acquired MRSA (CA-MRSA) in adult patients (>17yrs old) presenting with skin or soft tissue infections to the emergency departments (EDs) of an academic health care setting in London, Ontario. Secondary objectives will include the identification of demographic and clinical variables associated with MRSA, characterization of MRSA antimicrobial susceptibilities and genotypes, and determining the effects of treatment on MRSA colonization. We believe that the prevalence of MRSA and CA-MRSA in London, Ontario will be lower than rates recently published by academic hospitals from the United States. The hypothesis of the study is that patients presenting to the Emergency Departments in London, Ontario with skin and soft tissue infections will have a 10% prevalence of CA-MRSA, but certainly the prevalence may be much higher.
Purpose: Results from this research may be used as part of the guidelines for empirical S aureus treatment in the region, thus reducing possible morbidity and mortality from delayed or suboptimal treatment of CA-MRSA infections. This information, along with an improved understanding of risk factors associated with MRSA infection in a Canadian setting, has the potential to change the practice of physicians who are considering empiric antibiotic therapy for skin and soft tissue infections.
This study will focus on the epidemiology of patients with skin or soft tissue infections presenting to the adult emergency departments (EDs) at the London Health Sciences Centre (LHSC) and the Urgent Care Center at St. Joseph's Health Centre (SJHC). By using a comparison group of non CA-MRSA infections, the proportion of CA-MRSA with relation to the total MRSA and methicillin sensitive Staphylococcus aureus (MSSA) in the region will be investigated. The study will also investigate the risk factors in the CA-MRSA population including: demographics, housing history, contact with the health care system, past CA-MRSA infection, asymptomatic CA-MRSA colonization, colonization/infection of close contacts, involvement in contact sports/team sports, hygienic body shaving, chronic skin disorders, recurrent/recent antibiotic use, IV drug use, contact with incarcerated individuals, and chronic disease.
Through follow-up visits at one and three months involving nares and throat swabs of patients initially testing positive for MRSA the effects of treatment on MRSA colonization will be determined. Furthermore, a follow-up questionnaire will be administered to all patients at one month to determine complication rates for patients colonized with MRSA versus those not colonized.
The current recommendations for antibiotic treatment of unknown S. aureus infection are based on clinical judgment, and therefore an understanding of regional incidence and susceptibility of CA-MRSA are essential for empiric treatment. Through the microbiological analysis of the cases, laboratory parameters and antibiotic susceptibility of CA-MRSA presenting to LHSC will be established. As well, the clinical characteristics of these patients will be documented to aid clinicians in recognizing patients presenting with CA-MRSA.
Experimental Design: This study will be a prospective prevalence study involving adult patients (>17years old) with skin and soft-tissue infections presenting to the Emergency Departments of LHSC (University Hospital and Victoria Hospital) as well as to the Urgent Care of SJHC. These departments have a combined approximate total of 150,000 visits per year. The study has an expected enrollment of 152 patients from July 2008- July 2009. The study will continue until three months after the last patient has been enrolled so that follow-up nasal and throat swabs may be obtained, if applicable.
n = Z2 P (1-P) / d2 n = 1.962 * .10 (1- .10) / 0.052 n = 3.8416 * .10 * .90 / .0025 n = 138
While the investigators do not anticipate a problem with non-response or missing values, to take this into consideration, we will over-sample the above sample size by 10%. Therefore, we will recruit at least 152 patients to the study. Therefore, assuming 80% power, an estimated prevalence of 10%, and a precision level of 5%, 152 patients are needed to be 95% confident that the true proportion of MRSA in adult patients (>17yrs old) presenting with skin or soft tissue infections will be between 5% and 15%.
Written, informed consent will be obtained from all patients that meet the study inclusion criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Selection of Participants: The objective of this prospective study is to determine the prevalence of MRSA and community acquired MRSA (CA-MRSA) in adult patients (>17 yrs old) presenting with skin or soft tissue infections to the emergency departments (EDs) of an academic health care setting in London, Ontario.
Key inclusion criteria (1 listed)
- All adult patients (> 17 years) whose chief complaint is consistent with skin or soft tissue infection (cellulitis, necrotizing soft tissue infection, wound infection, ulcer, septic bursitis, abscess including furuncle/carbuncle/superficial skin abscess, paronychia, hordeolum, pilonidal abscess, acute lymphadenitis, pilonidal cyst without abscess, and impetigo).
Key exclusion criteria (2 listed)
- Patients will be excluded if they refuse to participate or written, informed consent is not obtained.
- Additionally, patients with Bartholin cysts, odontogenic infections and perianal abscesses will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 5 Jan 2011.
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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.
Christopher MB Fernandes, FRCP, FACEP, MD principal investigator
The University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections and Gram-Positive Bacterial Infections, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 2 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 5 Jan 2011. 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 Canada. 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. 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.
Where can I read the original study information?
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 5 Jan 2011.