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?

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
McLaren Greater Lansing
RECRUITING
Lansing
University of Michigan Health/Sparrow (name change only)
RECRUITING
Lansing
Contact Information
Primary
Mary J Hughes, DO
hughesm@msu.edu
517-353-3211
Backup
Brett Etchebarne, MD PhD
madcow@msu.edu
517-353-3211
Time Frame
Start Date: 2015-06
Estimated Completion Date: 2032-07
Participants
Target number of participants: 2500
Treatments
SIRS positive
Adult (\> or = 18 years) 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, or those with a source of infection in any other bodily fluid suspected to be the source of infection. May also include others without SIRS criteria but with bodily fluid production or infection of a bodily fluid
Authors
Walid Khalife, Brett Etchebarne
Related Therapeutic Areas
Sponsors
Leads: Michigan State University

This content was sourced from clinicaltrials.gov