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?

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by Michigan State University
Sponsor:
Information provided by (Responsible Party):
Mary Hughes, Michigan State University
ClinicalTrials.gov Identifier:
NCT01904188
First received: July 17, 2013
Last updated: September 7, 2014
Last verified: September 2014
  Purpose

The aim of this project is to test the utility of the Gene-Z device on clinically obtained bodily fluid samples taken from patients with suspected sepsis based on having three of four positive Systemic Inflammatory Response Syndrome markers. 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 accurately. 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.


Condition Intervention
Sepsis
Systemic Inflammatory Response Syndrome
Device: Gene Z

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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?

Resource links provided by NLM:


Further study details as provided by Michigan State University:

Primary Outcome Measures:
  • Correlation of microbial identification with culture results from clinical laboratory [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Frozen microbial specimens will be transported to an off site laboratory for analysis with the GeneZ device, with investigators blinded to the final culture results of the specimen - positive or negative. Comparison will be made between final culture result and GeneZ identification of organism.


Secondary Outcome Measures:
  • Microbial Resistance Gene Pattern [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Frozen specimens will be transported to an offsite laboratory where real time PCR will be used to identify microorganism resistance gene patterns of organisms identified by the GeneZ device. These will be compared to the antibiotic sensitivity results from the culture and sensitivity reports done in the clinical laboratory.


Biospecimen Retention:   None Retained

No specimens will be retained after analysis by study investigators. Prior to being sent to the laboratory they will be retained in frozen state until there is a large enough quantity to batch run specimens.


Estimated Enrollment: 300
Study Start Date: November 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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, along with any other bodily fluid suspected to be the source of infection.
Device: Gene Z
The Gene Z device 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 will be used to re-analyze at a later date specimens that were previously frozen and stored and compared to culture results

Detailed 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 20 minutes of a routine Emergency Department laboratory blood draw or urine 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 timeframe. 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 our 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 our 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). To date we have validated this approach with laboratory-processed samples of Escherichia coli and Staphylococcus aureus. POC testing will now be expanded to include additional microorganisms commonly encountered in sepsis patients. Secondarily, antimicrobial resistance genes will be scanned using a functional genomics approach with highly-parallel quantitative PCR as performed by our laboratory in a previous study exploring the microbiota of porcine gastrointestinal tract.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All adult patients who undergo evaluation for suspected sepsis who have peripheral blood cultures and urine samples obtained and patient characteristics recorded. Those that have other bodily fluids in addition will also be included.

Criteria

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.

Exclusion Criteria:

Pediatric patients Adult patients with less than 3 of 4 systemic inflammatory response syndrome (SIRS) characteristics

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01904188

Contacts
Contact: Mary J Hughes, DO 517-353-3211 hughesm@msu.edu

Locations
United States, Michigan
Sparrow Health System Recruiting
Lansing, Michigan, United States, 48909
Contact: Walid Khalife, PhD    517-364-2170    walid.khalife@sparrow.org   
Sub-Investigator: Brett Etchebarne, MD/PhD         
Sub-Investigator: Walid Khalife, PhD         
Principal Investigator: Mary J Hughes, DO         
Sub-Investigator: Syed A Hashsham, PhD         
Sub-Investigator: James Tiedje, PhD         
Sponsors and Collaborators
Michigan State University
Investigators
Principal Investigator: Mary J Hughes, DO Michigan State University
  More Information

No publications provided

Responsible Party: Mary Hughes, Professor of Emergency Medicine, Chair Department of Osteopathic Medical Specialties, Michigan State University
ClinicalTrials.gov Identifier: NCT01904188     History of Changes
Other Study ID Numbers: C13-033F
Study First Received: July 17, 2013
Last Updated: September 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Michigan State University:
microbial identification
antibiotic resistance
GeneZ
sepsis
Systemic Inflammatory Response Syndrome

Additional relevant MeSH terms:
Syndrome
Systemic Inflammatory Response Syndrome
Disease
Pathologic Processes
Inflammation
Shock
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on September 18, 2014