Actively Recruiting

Age: 18Years +
All Genders
NCT01904188

Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?

Led by Michigan State University · Updated on 2025-05-23

2500

Participants Needed

2

Research Sites

891 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The aim of this project is to test the utility of The Gene Z device (as of 2018 Gene Z no longer being used), now using In-Dx and other rapid identification techniques that the investigators have developed in the lab on clinically obtained bodily fluid samples taken from patients with suspected infection or sepsis based on having three of four positive Systemic Inflammatory Response Syndrome markers, or having a known infection for which a specimen is being collected. Specimens will be collected by University of Michigan Health/Sparrow Laboratories and McLaren Greater Lansing laboratories, processed and stored for analysis at a later date to determine if the microbial pathogens identified by current methods of culture, as well as pathogen susceptibility to antibiotics by culture results, can be identified by the GeneZ technology (no longer in use) or other developed technology accurately, and more timely. It will not affect current patient care nor impact patient care, which will continue in the standard fashion today for sepsis. Results will be compared to standard culture results and antibiotic sensitivities.

CONDITIONS

Official Title

Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients with three of four systemic inflammatory response syndrome (SIRS) signs: rapid heartbeat, fever or low temperature, rapid breathing, or high white blood cell count
  • Patients with other infection sources with fewer than three SIRS signs
  • Blood cultures and urine or other bodily fluids collected for infection evaluation
Not Eligible

You will not qualify if you...

  • Pediatric patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

M

Mary J Hughes, DO

CONTACT

B

Brett Etchebarne, MD PhD

CONTACT

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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