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?
Michigan State University
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.
Description
Dramatic improvement in the timely and effective treatment of patients afflicted with sepsis can be achieved with the implementation of modern technologies for identification of offending microbial species and their innate genetic antibiotic treatment targets. Our collaborative team is planning to address this need using a Point-of-Care (POC) device equipped for identification of a bacterial species within 60 minutes of a routine Emergency Department laboratory blood draw or other specimen collection, followed by targeted analysis of its innate genetic antibiotic resistance elements within as…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Adult patients with 3 of 4 systemic inflammatory response syndrome (SIRS) characteristics (1. tachycardia, 2. fever or hypothermia, 3. tachypnea, 4. leukocytosis), who have blood cultures drawn and urine collected for the evaluation of suspected sepsis, and/or other bodily fluids collected for culture and sensitivity analysis. Patients with other sources of infection with less than 3 of 4 SIRS criteria Exclusion Criteria: Pediatric patients
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
Locations (2)
- University of Michigan Health/Sparrow (name change only)Lansing, Michigan
- McLaren Greater LansingLansing, Michigan