Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?
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) 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 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 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.
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 little as 7 hours time. This
 revolutionary improvement in clinical management is critical for improving patient outcomes
 for a disease syndrome that is not only highly prevalent worldwide, consuming a massive
 amount of medical resources daily, but that only threatens to continue to worsen given
 current antibiotic stewardship practices. Early goal-directed therapy (EGDT) is the standard
 by which medical interventions are now shaped across fields in the modern clinical setting,
 ranging from trauma and neurosurgery to cardiology and infectious disease. Rapid and accurate
 diagnoses, paired with aggressive and effective intervention, are manifest to stemming the
 disease process as well as maintaining economically feasible care and improving long-term
 morbidity. The effort to apply EGDT to patients at high risk for systemic infection, sepsis,
 was initiated over a decade ago by Rivers and colleagues in the Emergency Department setting.
 Systematic approaches to early sepsis identification and intervention including
 broad-spectrum antibiotic coverage, and adequate fluid volume resuscitation have yielded
 definite improvements in patient outcomes and health care resource utilization. It has been
 recognized that one of the limiting factors in treatment of sepsis in the hospital setting is
 the timeliness of pathogen identification and implementation of appropriate antimicrobial
 therapy. The current "gold standard" of sepsis microbial identification is blood culture,
 which takes 3-5 days for a definitive species identification. Antimicrobial agent
 susceptibility for the given organism is generally garnered within this same time frame.
 However, in the period it takes from specimen collection to culture results, empiric
 broad-spectrum antibiotic coverage, often involving multiple antibiotics, must be provided to
 ensure organism eradication. This proposal aims to use Point of Care (POC) testing, as
 described by the investigatos' laboratory, to accurately identify pathogenic microorganisms
 in patients with suspected sepsis within 20 minutes of a laboratory blood draw or urine
 collection. The scope of the investigators' proposal is feasible in that 20 organisms account
 for 87% of microbial infections identified by culture-based techniques at Sparrow Hospital,
 representing the greater Lansing, Michigan area, and 50 microorganisms would account for
 virtually every microbial infectious species (Khalife, 2011, unpublished data). In
 preliminary studies the investigators have validated this approach with laboratory-processed
 samples of Escherichia coli and Staphylococcus aureus. The investigators now are creating
 panels for multiple types of infections and have validated these efforts on over 30
 microorganisms. POC testing will now be expanded to include additional microorganisms
 commonly encountered in sepsis patients or those with other identifiable infectious sources.
 Secondarily, antimicrobial resistance genes will be scanned using a functional genomics
 approach with highly-parallel quantitative PCR as performed by the investigators' laboratory
 in a previous study exploring the microbiota of porcine gastrointestinal tract.
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