NCT01904188 Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?
| NCT ID | NCT01904188 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Michigan State University |
| Condition | Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2015-06 |
| Primary Completion | 2030-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2015-06 with a primary completion date of 2030-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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/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
Contact & Investigator
Mary J Hughes, DO
PRINCIPAL INVESTIGATOR
Michigan State University
Frequently Asked Questions
Who can join the NCT01904188 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01904188 currently recruiting?
Yes, NCT01904188 is actively recruiting participants. Contact the research team at hughesm@msu.edu for enrollment information.
Where is the NCT01904188 trial being conducted?
This trial is being conducted at Lansing, United States, Lansing, United States.
Who is sponsoring the NCT01904188 clinical trial?
NCT01904188 is sponsored by Michigan State University. The principal investigator is Mary J Hughes, DO at Michigan State University. The trial plans to enroll 2,500 participants.