Methicillin-Resistant Staphylococcus AureusNCT02363166
Analysis of CA-MRSA Transmission: An ED Population Sampling Strategy
An observational study of Methicillin-Resistant Staphylococcus Aureus, run by University of Florida at 1 site in United States.
Trial summary
Given that the Emergency Department (ED) has become the entry way for large populations of patients into the health care system, a strategy of sampling MRSA isolates in ED populations and merging this information with patient-level data may present a window to hypothesize and investigate CA-MRSA transmission within… Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Methicillin-Resistant Staphylococcus Aureus
- What is being tested?
- Acute Abscess Group
- How many people
- 575 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 4 Apr 2018
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and pediatric patients presenting to the UFHealth Shands Emergency Department with evidence of an acute abscess, or skin/soft tissue infection (SSTI), which can be sampled for culture and sensitivity testing
Who may be able to join
- Patient or Legally Authorized Representative (LAR) must have voluntarily signed an Institutional Review Board-approved informed consent form before initiation of any study procedures
- Patient presents with an acute abscess or a non-post-operative skin/soft tissue infection
- Patient presents through the UFHealth Shands Emergency Department
Who cannot join
- Patients who are employed by UFHealth and provide direct patient care
- Patients who have previously been enrolled in the study
- Patients who are not suitable for the study in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Epidemiology and Phylodynamic and Phylogeographic Analysis of Community-associated Methicillin-resistant Staphylococcus Aureus (CA-MRSA) Transmission: An Emergency Department Population Sampling Strategy
Given that the Emergency Department (ED) has become the entry way for large populations of patients into the health care system, a strategy of sampling MRSA isolates in ED populations and merging this information with patient-level data may present a window to hypothesize and investigate CA-MRSA transmission within the community and its impact on hospital-acquired infections.
Read the detailed description
Prospective cross-sectional study involving 500 patients enrolled over a one year period at the UFHealth Shands Hospital's Adult and Pediatric Emergency Department. The collected information will serve as pilot data for a future large comprehensive multi-site study.
Patients will have a wound culture and a nasal swab obtained as part of the study, which will be assessed for MRSA isolates using next-generation whole genome sequencing. The principal investigator or PI designee will also survey participants and review hospital records.
- Being tested
- Acute Abscess Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Abscess GroupOther
Samples collected for culture and sensitivity testing depending on acute abscess, or skin/soft tissue infection.
| Study group | Role | What they receive |
|---|---|---|
| Acute Abscess Group | Adults and pediatric patients presenting to the UFHealth Shands Emergency Department with evidence of an acute abscess, or skin/soft tissue infection, which can be sampled for culture and sensitivity testing will be recruited. Receives: Other: Acute Abscess Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strain Relatedness Identification Through Phylogenetic Analysis
Molecular (spa-typing) and genomic (WGS) relatedness of MRSA strains in isolates in ED populations presenting with SSTIs.
Measured: 1 Hour
Secondary outcomes (3)
Strain Transmission Through Analysis of Genetic Clustering
Phlyodynamic analysis of MRSA transmission course by strain
Measured: 1 year
Patient Level Characteristics of Skin and Soft Tissue Infection (SSTI) Presentation
To determine patient-level characteristics, including social and medical history, associated with a presentation related to SSTIs.
Measured: 6 Months
Pediatric and Adult Population Presentation Characteristics in Skin and Soft Tissue Infection (SSTI)
Compare patient-level characteristics and phylogenetic clustering between pediatric and adult patients presenting with SSTIs.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startAug 2015
- Primary completion4 Apr 2018
- Study completion4 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 FloridaThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph A Tyndall, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363166
- Sponsor's protocol ID
- IRB201400426
- Status last verified
- Aug 2024
- First submitted
- 9 Feb 2015
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burton DC, Edwards JR, Horan TC, Jernigan JA, Fridkin SK. Methicillin-resistant Staphylococcus aureus central line-associated bloodstream infections in US intensive care units, 1997-2007. JAMA. 2009 Feb 18;301(7):727-36. doi: 10.1001/jama.2009.153.
PubMed 19224749Climo MW. Decreasing MRSA infections: an end met by unclear means. JAMA. 2009 Feb 18;301(7):772-3. doi: 10.1001/jama.2009.149. No abstract available.
PubMed 19224756Prosperi M, Veras N, Azarian T, Rathore M, Nolan D, Rand K, Cook RL, Johnson J, Morris JG Jr, Salemi M. Molecular epidemiology of community-associated methicillin-resistant Staphylococcus aureus in the genomic era: a cross-sectional study. Sci Rep. 2013;3:1902. doi: 10.1038/srep01902.
PubMed 23712667Park SH, Park C, Yoo JH, Choi SM, Choi JH, Shin HH, Lee DG, Lee S, Kim J, Choi SE, Kwon YM, Shin WS. Emergence of community-associated methicillin-resistant Staphylococcus aureus strains as a cause of healthcare-associated bloodstream infections in Korea. Infect Control Hosp Epidemiol. 2009 Feb;30(2):146-55. doi: 10.1086/593953.
PubMed 19128184Wu D, Wang Q, Yang Y, Geng W, Wang Q, Yu S, Yao K, Yuan L, Shen X. Epidemiology and molecular characteristics of community-associated methicillin-resistant and methicillin-susceptible Staphylococcus aureus from skin/soft tissue infections in a children's hospital in Beijing, China. Diagn Microbiol Infect Dis. 2010 May;67(1):1-8. doi: 10.1016/j.diagmicrobio.2009.12.006. Epub 2010 Mar 12.
PubMed 20227225
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Epidemiology and Phylodynamic and Phylogeographic Analysis of Community-associated Methicillin-resistant Staphylococcus Aureus (CA-MRSA) Transmission: An Emergency Department Population Sampling Strategy
- ClinicalTrials.gov ID
- NCT02363166
- Acronym / sponsor ID
- IRB201400426
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 13 Feb 2015 (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.
Given that the Emergency Department (ED) has become the entry way for large populations of patients into the health care system, a strategy of sampling MRSA isolates in ED populations and merging this information with patient-level data may present a window to hypothesize and investigate CA-MRSA transmission within the community and its impact on hospital-acquired infections.
Detailed description
Prospective cross-sectional study involving 500 patients enrolled over a one year period at the UFHealth Shands Hospital's Adult and Pediatric Emergency Department. The collected information will serve as pilot data for a future large comprehensive multi-site study.
Patients will have a wound culture and a nasal swab obtained as part of the study, which will be assessed for MRSA isolates using next-generation whole genome sequencing. The principal investigator or PI designee will also survey participants and review hospital records.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute Abscess Group | – | Other: Acute Abscess GroupAdults and pediatric patients presenting to the UFHealth Shands Emergency Department with evidence of an acute abscess, or skin/soft tissue infection, which can be sampled for culture and sensitivity testing will be recruited. |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and pediatric patients presenting to the UFHealth Shands Emergency Department with evidence of an acute abscess, or skin/soft tissue infection (SSTI), which can be sampled for culture and sensitivity testing
Key inclusion criteria (3 listed)
- Patient or Legally Authorized Representative (LAR) must have voluntarily signed an Institutional Review Board-approved informed consent form before initiation of any study procedures
- Patient presents with an acute abscess or a non-post-operative skin/soft tissue infection
- Patient presents through the UFHealth Shands Emergency Department
Key exclusion criteria (3 listed)
- Patients who are employed by UFHealth and provide direct patient care
- Patients who have previously been enrolled in the study
- Patients who are not suitable for the study in the opinion of the investigator
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 |
|---|---|---|
| Acute Abscess GroupSamples collected for culture and sensitivity testing depending on acute abscess, or skin/soft tissue infection. | Other | Acute Abscess Group |
Primary outcome
Strain Relatedness Identification Through Phylogenetic Analysis
Time frame: 1 Hour
Molecular (spa-typing) and genomic (WGS) relatedness of MRSA strains in isolates in ED populations presenting with SSTIs.
3 secondary outcomes
Strain Transmission Through Analysis of Genetic Clustering
Time frame: 1 year
Patient Level Characteristics of Skin and Soft Tissue Infection (SSTI) Presentation
Time frame: 6 Months
Pediatric and Adult Population Presentation Characteristics in Skin and Soft Tissue Infection (SSTI)
Time frame: 6 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 21 Aug 2024.
- Background: PubMed 19224749Burton DC, Edwards JR, Horan TC, Jernigan JA, Fridkin SK. Methicillin-resistant Staphylococcus aureus central line-associated bloodstream infections in US intensive care units, 1997-2007. JAMA. 2009 Feb 18;301(7):727-36. doi: 10.1001/jama.2009.153.
- Background: PubMed 19224756Climo MW. Decreasing MRSA infections: an end met by unclear means. JAMA. 2009 Feb 18;301(7):772-3. doi: 10.1001/jama.2009.149. No abstract available.
- Background: PubMed 23712667Prosperi M, Veras N, Azarian T, Rathore M, Nolan D, Rand K, Cook RL, Johnson J, Morris JG Jr, Salemi M. Molecular epidemiology of community-associated methicillin-resistant Staphylococcus aureus in the genomic era: a cross-sectional study. Sci Rep. 2013;3:1902. doi: 10.1038/srep01902.
- Background: PubMed 19128184Park SH, Park C, Yoo JH, Choi SM, Choi JH, Shin HH, Lee DG, Lee S, Kim J, Choi SE, Kwon YM, Shin WS. Emergence of community-associated methicillin-resistant Staphylococcus aureus strains as a cause of healthcare-associated bloodstream infections in Korea. Infect Control Hosp Epidemiol. 2009 Feb;30(2):146-55. doi: 10.1086/593953.
- Background: PubMed 20227225Wu D, Wang Q, Yang Y, Geng W, Wang Q, Yu S, Yao K, Yuan L, Shen X. Epidemiology and molecular characteristics of community-associated methicillin-resistant and methicillin-susceptible Staphylococcus aureus from skin/soft tissue infections in a children's hospital in Beijing, China. Diagn Microbiol Infect Dis. 2010 May;67(1):1-8. doi: 10.1016/j.diagmicrobio.2009.12.006. Epub 2010 Mar 12.
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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.
Joseph A Tyndall, MD principal investigator
University of Florida
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 Methicillin-Resistant Staphylococcus Aureus, run by University of Florida 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 3 inclusion and 3 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 21 Aug 2024. 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. 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?
Strain Relatedness Identification Through Phylogenetic Analysis (time frame: 1 Hour). 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 NCT02363166, which also lists 5 linked publications.
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 21 Aug 2024.