Analysis of CA-MRSA Transmission: An ED Population Sampling Strategy
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ClinicalTrials.gov Identifier: NCT02363166 |
Recruitment Status :
Recruiting
First Posted : February 13, 2015
Last Update Posted : June 13, 2023
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Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
Tracking Information | |||||||||
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First Submitted Date | February 9, 2015 | ||||||||
First Posted Date | February 13, 2015 | ||||||||
Last Update Posted Date | June 13, 2023 | ||||||||
Actual Study Start Date | August 2015 | ||||||||
Estimated Primary Completion Date | February 5, 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
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.
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Analysis of CA-MRSA Transmission: An ED Population Sampling Strategy | ||||||||
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 | ||||||||
Brief 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 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. |
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Study Type | Observational | ||||||||
Study Design | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Retention: Samples With DNA Description: Genomic DNA (gDNA) will be isolated from pelleted bacteria using the Roche High Pure PCR kit following the standard protocol for isolation of nucleic acids from bacteria. The quality of the extracted gDNA will be determined through gel electrophoresis and the quantity through Nanodrop2000.
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Sampling Method | Non-Probability Sample | ||||||||
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 | ||||||||
Condition | Methicillin-Resistant Staphylococcus Aureus | ||||||||
Intervention | Other: Acute Abscess Group
Samples collected for culture and sensitivity testing depending on acute abscess, or skin/soft tissue infection.
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Study Groups/Cohorts | 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.
Intervention: Other: Acute Abscess Group
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
575 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | February 5, 2025 | ||||||||
Estimated Primary Completion Date | February 5, 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 1 Month and older (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT02363166 | ||||||||
Other Study ID Numbers | IRB201400426 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||||
Current Responsible Party | University of Florida | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor | University of Florida | ||||||||
Original Study Sponsor | Same as current | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | University of Florida | ||||||||
Verification Date | June 2023 |