Actively Recruiting
Clinical Microbial Species and Antibiotic Resistance Identification in Patients Presenting to the Emergency Department With Three of Four Systemic Inflammatory Response Syndrome Criteria - Is Rapid Identification Possible and Accurate?
Led by Michigan State University · Updated on 2026-06-08
2500
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the Gene Z device and other rapid diagnostic techniques developed in the lab to quickly identify microbial species and antibiotic resistance in patients suspected of infection or sepsis. The study involves adults who show signs of systemic inflammatory response syndrome (SIRS) or have a known infection where specimens are collected. The goal is to see if these new methods can accurately and more rapidly detect pathogens compared to standard culture methods, which can take several days. Additionally, the study aims to explore genetic factors in the microbes and patients that may affect antibiotic resistance and disease severity. The study uses specimens collected from blood, urine, and other bodily fluids such as sputum, wound drainage, cerebrospinal fluid, and nasal or oral secretions. These samples are processed and stored for later analysis using the Gene Z device (no longer used as of 2018) and newer rapid identification technologies like In-Dx. The results will be compared to traditional culture and antibiotic sensitivity testing to assess accuracy and timeliness. The study includes patients with at least three of four SIRS criteria or those with infections not meeting the full SIRS criteria. Participants provide samples during routine clinical care, which is not altered by the study. Researchers analyze microbial identification, antibiotic resistance gene patterns, and, with separate permission, human genome data to understand factors influencing disease progression. The primary outcome is the correlation of rapid identification results with standard culture findings over up to one year per specimen. Secondary outcomes include resistance gene patterns and human genome analysis. The study is observational and will continue through July 2032.
CONDITIONS
Brief Title
Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with at least three of four systemic inflammatory response syndrome (SIRS) signs: fast heart rate, fever or low body temperature, rapid breathing, or high white blood cell count
- Patients who have blood cultures drawn and/or urine or other body fluids collected for suspected sepsis or infection
- Patients with infections from other sources such as sputum, wound drainage, cerebrospinal fluid, nasal or oral secretions, even if they have fewer than three SIRS signs
You will not qualify if you...
- Pediatric patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants who meet criteria based on clinical signs and specimen collection are included.
Duration - Up to one year per specimen
Participants provide specimens such as blood, urine, or other body fluids which are analyzed using rapid diagnostic devices and standard culture methods.
Specimens collected during routine care; no additional visits required for study purposes.
Duration - Up to one year per specimen
Participants are observed to correlate microbial identification results and analyze microbial resistance gene patterns and, with permission, human genome analysis related to disease severity.
Follow-up assessments based on specimen analysis timeline; no scheduled visits required.
Trial Site Locations
Total: 2 locations
1
University of Michigan Health/Sparrow (name change only)
Lansing, Michigan, United States, 48909
Actively Recruiting
2
McLaren Greater Lansing
Lansing, Michigan, United States, 48910
Actively Recruiting
Research Team
M
Mary J Hughes, DO
B
Brett Etchebarne, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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