Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?

NCT01904188 | Recruiting

• 1 other identifier: C13-033F
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 2

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; Antibiotic Resistance Genes; Human Genome Analysis; Infection Mixed; Infection, Bacterial; Infection, Fungal; Infection, Coronavirus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlation of microbial identification with culture results from clinical laboratory

  Frozen microbial specimens will be transported to an off site laboratory for analysis with the GeneZ or other point of care or rapid diagnostic technique or 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 or other method as developed in the investigators' lab.

  up to one year per specimen

Secondary Outcomes (2)

• Microbial Resistance Gene Pattern

  up to one year per specimen

• Human genome analysis in consented patients

  one year per specimen

Study Arms (1)

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.

Device: 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)

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) DEVICE

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

SIRS positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who undergo evaluation for suspected sepsis who have peripheral blood cultures and/or urine samples obtained and patient characteristics recorded. In addition those that have an obvious infection without sepsis will be consented. Those that have other bodily fluids involved in addition will also be included, with or without SIRS criteria. (Sputum, wound drainage, CSF, oral or nasal secretions).

You may qualify if:

• 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.

You may not qualify if:

• Pediatric patients

Sponsors & Collaborators

• Michigan State University: lead

Study Sites (2)

University of Michigan Health/Sparrow (name change only)

Lansing, Michigan, 48909, United States

RECRUITING

McLaren Greater Lansing

Lansing, Michigan, 48910, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Prior to being analyzed the specimens will be retained in frozen state until there is a large enough quantity to batch run specimens in our investigational lab.

MeSH Terms

Conditions

Sepsis; Systemic Inflammatory Response Syndrome; Coinfection; Bacterial Infections; Mycoses; Coronavirus Infections

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Bacterial Infections and Mycoses; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases

Study Officials

• Mary J Hughes, DO

  Michigan State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary J Hughes, DO

CONTACT

517-353-3211; hughesm@msu.edu

Brett Etchebarne, MD PhD

CONTACT

517-353-3211; madcow@msu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine, Chair Department of Osteopathic Medical Specialties

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 22, 2013
• Study Start: June 1, 2015
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2032
• Last Updated: June 8, 2026

Record last verified: 2025-05

Locations

US (2)