RecruitingNCT01904188

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

Clinical Microbial Species and Antibiotic Resistance Identification in Patients Presenting to the Emergency Department With Three of Four Systemic Inflammatory Response Syndrome (SIRS) Criteria - is Rapid Identification Possible and Accurate?

Sponsor

Michigan State University

Enrollment

2,500 participants

Start Date

Jun 1, 2015

Study Type

OBSERVATIONAL

Conditions

Sepsis Systemic Inflammatory Response Syndrome Infection, Bacterial Infection, Fungal Infection Mixed Infection, Coronavirus

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a rapid diagnostic technology to identify bacteria and antibiotic resistance in blood, urine, and other bodily fluid samples from adult patients presenting to the Emergency Department with suspected infections or sepsis. The goal is to determine whether this technology can quickly and accurately identify harmful pathogens to guide faster, better-targeted treatment decisions. You may be eligible if... - You are an adult presenting to the emergency department with signs of a serious infection (sepsis) - You show at least 3 of the 4 SIRS criteria: rapid heart rate, fever or low body temperature, rapid breathing, or abnormal white blood cell count - You have blood cultures, urine, or other bodily fluids collected as part of your clinical care - You may also be eligible if you have fewer SIRS signs but another clear source of infection You may NOT be eligible if... - You are a pediatric (child) patient Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEGene Z or other rapid diagnostic techniques developed in our lab (as of 2018 not using Gene Z - now using In-Dx along with other developed techniquesregularly)

The Gene Z device (no longer in use) and now using In-Dx created in our lab, and other rapid diagnostic techniques that we have developed in our lab will be used to analyze previously processed specimens for microbial organisms and compared to prior culture and sensitivity results. It is not a separate arm - all samples will be cultured in lab per standard protocol and then the Gene Z device or other rapid diagnostic techniques developed in our lab will be used to re-analyze at a later date specimens that were previously frozen and stored and compared to culture results