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?
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|ClinicalTrials.gov Identifier: NCT01904188|
Recruitment Status : Recruiting
First Posted : July 22, 2013
Last Update Posted : August 30, 2017
|Condition or disease||Intervention/treatment|
|Sepsis Systemic Inflammatory Response Syndrome||Device: Gene Z|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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?|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
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
- Correlation of microbial identification with culture results from clinical laboratory [ Time Frame: 1 year ]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.
- Microbial Resistance Gene Pattern [ Time Frame: 1 year ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904188
|Contact: Mary J Hughes, DOemail@example.com|
|United States, Michigan|
|Sparrow Health System||Recruiting|
|Lansing, Michigan, United States, 48909|
|Contact: Walid Khalife, PhD 517-364-2170 firstname.lastname@example.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|
|Principal Investigator:||Mary J Hughes, DO||Michigan State University|