RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 by University of Michigan Health/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 (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.

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?

Quick Facts

Study Start:2015-06
Study Completion:2032-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01904188

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Mary J Hughes, DO
CONTACT
517-353-3211
hughesm@msu.edu
Brett Etchebarne, MD PhD
CONTACT
517-353-3211
madcow@msu.edu

Principal Investigator

Mary J Hughes, DO
PRINCIPAL_INVESTIGATOR
Michigan State University

Study Locations (Sites)

University of Michigan Health/Sparrow (name change only)
Lansing, Michigan, 48909
United States
McLaren Greater Lansing
Lansing, Michigan, 48910
United States

Collaborators and Investigators

Sponsor: Michigan State University

  • Mary J Hughes, DO, PRINCIPAL_INVESTIGATOR, Michigan State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-06
Study Completion Date2032-07

Study Record Updates

Study Start Date2015-06
Study Completion Date2032-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Sepsis
  • Systemic Inflammatory Response Syndrome
  • Infection Mixed
  • Infection, Bacterial
  • Infection, Fungal
  • Infection, Coronavirus