Recruiting

Rapid Identification Techniques

Sponsor:

Michigan State University

Code:

NCT01904188

Conditions

Sepsis

Systemic Inflammatory Response Syndrome

Infection Mixed

Infection, Bacterial

Infection, Fungal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gene 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)

Study Details

Brief 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 at the University of Michigan Health/Sparrow and McLaren Greater Lansing , processed in our lab 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. A secondary aim is related to the antibiotic resistance of the organism causing the infection in an attempt to determine if there are specific characteristics of the organism that allow it to be resistant to certain antibiotics. This requires analysis of the genetic material of the organism in our laboratory. Because there are also human cells in the specimens collected, with separate permission we will evaluate the human genome of the patient with the infection to determine characteristics and conditions that may predict a complicated versus uncomplicated disease course.

Conditions

Sepsis

Systemic Inflammatory Response Syndrome

Infection Mixed

Infection, Bacterial

Infection, Fungal

Study ID

NCT01904188

Start date

Jun, 2015

Status verified date

May, 2025

Completion date

Jul, 2032

Anticipated

Primary completion date

Jul, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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/or 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 including sputum, wound drainage, CSF, nasal or oral secretions.

Exclusion Criteria:

Pediatric patients

Study Design

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Arms

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/or 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. (Sputum, stool, saliva, nasal secretions, CSF, wound drainage) May also include others without SIRS criteria but with bodily fluid production or infection of a bodily fluid. With separate permission will analyze human genome and compare characteristics to severity of illness experienced.

Interventions

Gene 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

Primary outcome measure

  • Correlation of microbial identification with culture results from clinical laboratory [ Time Frame: up to one year per specimen ]

Central Contacts and Locations

Central contacts

Mary J Hughes, DO

517-353-3211hughesm@msu.edu

Brett Etchebarne, MD PhD

517-353-3211madcow@msu.edu

Locations

University of Michigan Health/Sparrow (name change only)

Recruiting

Lansing, Michigan, United States, 48909

Contacts

Brett Etchebarne, MD PhD

517-353-3211madcow@msu.edu

Principal Investigator:

Mary J Hughes, DO

McLaren Greater Lansing

Recruiting

Lansing, Michigan, United States, 48910

Contacts

Mary Hughes, DO

5173533211hughesm@msu.edu

More Information

Sponsor

Michigan State University

Last update posted

Jun 8, 2026

Last verified

May, 2025

Keywords

  • microbial identification
  • antibiotic resistance
  • In-Dx and other methods as developed
  • sepsis
  • Systemic Inflammatory Response Syndrome
  • antibiotic resistance genes
  • human genome analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Michigan State University on 2026-06-08.