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

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 at the University of Michigan Health/Sparrow and McLaren Greater Lansing , processed in our lab 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. A secondary aim is related to the antibiotic resistance of the organism causing the infection in an attempt to determine if there are specific characteristics of the organism that allow it to be resistant to certain antibiotics. This requires analysis of the genetic material of the organism in our laboratory. Because there are also human cells in the specimens collected, with separate permission we will evaluate the human genome of the patient with the infection to determine characteristics and conditions that may predict a complicated versus uncomplicated disease course.

NCT Number	NCT01904188
Lead Sponsor	Michigan State University
Conditions	Sepsis, Systemic Inflammatory Response Syndrome, Infection Mixed, Infection, Bacterial, Infection, Fungal, Infection, Coronavirus, Antibiotic Resistance Genes, Human Genome Analysis
Enrollment	2,500 participants
Start Date	2015-06
Primary Completion	2030-07 (estimated)
Study Completion	2032-07 (estimated)
Updated on ClinicalTrials.gov	2026-06-08