Rapid Diagnostic Techniques for Sepsis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new methods to quickly identify bacteria and antibiotic resistance in individuals suspected of having an infection or sepsis (a serious infection that can spread throughout the body). Researchers are testing a device called In-Dx, along with other lab-developed methods, such as Gene Z (a rapid diagnostic technique), to determine if they can identify infections faster and more accurately than traditional lab cultures. The trial does not alter current patient treatment but aims to improve future testing methods. It seeks adults who exhibit specific signs of infection, such as a high heart rate, fever, or unusual white blood cell counts, and are having samples collected for suspected sepsis or other infections. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could revolutionize infection diagnosis.
Do I need to stop my current medications for the trial?
The trial does not specify whether you need to stop taking your current medications. It mentions that patient care will continue as usual, so it's likely you can keep taking your medications.
What prior data suggests that these rapid diagnostic techniques are safe for identifying infections?
Research shows that rapid diagnostic tools for infections, like those being tested, are generally safe and easy to use. These tools primarily work with samples taken from outside the body, reducing the risk of side effects compared to treatments administered internally.
Studies indicate that these tools can quickly identify infections and enable doctors to select the appropriate antibiotics more swiftly. This is particularly beneficial for treating serious infections like sepsis, which can spread throughout the body.
Although specific safety data directly linked to these tools is not available, they are considered low-risk because they are used for diagnosis. The aim is to assist doctors in diagnosing infections more quickly and accurately, without altering current treatment.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the potential of Gene Z and other rapid diagnostic techniques to quickly and accurately identify microbial species and antibiotic resistance in patients with infections. Unlike traditional methods that can take days to provide results, these new techniques promise to deliver information in a fraction of the time, potentially within hours. Faster identification of the infection-causing microbes and their resistance patterns can lead to more timely and targeted treatments, reducing the risk of complications and improving patient outcomes.
What evidence suggests that these rapid diagnostic techniques are effective for identifying infections or sepsis?
This trial will evaluate the effectiveness of Gene Z and other rapid diagnostic techniques developed in the lab. Research has shown that quick testing methods can significantly speed up and improve the accuracy of infection identification. Studies have found that these new techniques detect bacterial infections faster than older methods, which often take days. Results can be available in just a few hours, crucial for serious conditions like sepsis, where every moment counts. Early evidence suggests these methods can help determine the most effective antibiotics against the infection, potentially leading to more precise and successful treatments. Overall, rapid testing offers hope for better outcomes in patients with severe infections.13678
Who Is on the Research Team?
Mary J Hughes, DO
Principal Investigator
Michigan State University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Specimen Collection and Initial Analysis
Specimens are collected from patients with suspected infection or sepsis and analyzed using rapid identification techniques
Point-of-Care Testing
Point-of-Care device used to identify microbial species and antibiotic resistance within 60 minutes to 7 hours
Follow-up
Participants are monitored for safety and effectiveness after specimen analysis
What Are the Treatments Tested in This Trial?
Interventions
- Gene Z or other rapid diagnostic techniques developed in our lab
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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, or those with a source of infection in any other bodily fluid suspected to be the source of infection. May also include others without SIRS criteria but with bodily fluid production or infection of a bodily fluid
Find a Clinic Near You
Who Is Running the Clinical Trial?
Michigan State University
Lead Sponsor
Citations
Systemic Inflammatory Response Syndrome - StatPearls - NCBI
Systemic inflammatory response syndrome (SIRS) represents an exaggerated immune response to a range of stressors, including infections, trauma, ...
Rapid diagnosis of sepsis - PMC
The authors concluded that sTREM-1 has only a moderate diagnostic accuracy for differentiating sepsis from SIRS although sensitivity and specificity were ...
The Clinical Impact of Rapid Molecular Microbiological ...
The mortality rate of patients with sepsis is 10%–20%, which increases to 40%–80% in patients developing septic shock [2].
The 'analysis of gene expression and biomarkers for point- ...
Results: Nineteen high-performance, differentially expressed mRNA biomarkers were identified between control and combined SIRS/Sepsis groups (FC>20.0, p<0.05), ...
Assessment of Clinical Criteria for Sepsis
This cohort study uses health system and research cohort data to compare the ability of existing vs new clinical criteria for sepsis to ...
GENFIT Presents Promising New Preclinical Data on NTZ ...
Preclinical studies demonstrated significant efficacy on systemic inflammation and organ function in ACLF disease models; Safety data from ...
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the-hospitalist.org
the-hospitalist.org/hospitalist/article/37657/critical-care/precision-medicine-in-sepsis-diagnosis/Precision Medicine in Sepsis Diagnosis
This article aims to review current diagnostic methods and discuss emerging techniques in precision medicine in sepsis diagnosis.
Fast Track Diagnostic Tools for Clinical Management of ...
In comparison to the conventional method, modern methods are capable of analyzing blood samples, obtaining accurate results from the suspicious patient of ...
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