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NCT01904188 · ClinicalTrials.gov registry record
Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?
A clinical trial of Sepsis and Systemic Inflammatory Response Syndrome, sponsored by Michigan State University.
- Recruiting
- Registry status
- 2,500
- Enrollment target
- 2
- Study locations
NCT01904188 is a study of Sepsis and Systemic Inflammatory Response Syndrome that is actively recruiting participants, run by Michigan State University. The registered enrollment target is 2,500 participants, below the 6,537-participant average among 90 other Sepsis trials with a reported enrollment target (62% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01904188, a study of Sepsis and Systemic Inflammatory Response Syndrome, is actively recruiting participants, sponsored by Michigan State University.
- RECRUITING
- Registry status
- 2,500 participants
- Enrollment target
- 2
- Study locations
Study 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 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.
Conditions Studied
Interventions
- 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)
Study Locations (2)
Michigan
- University of Michigan Health/Sparrow (name change only) - Lansing
- McLaren Greater Lansing - Lansing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,500 participants |
| Start Date | 2015-06 |
| Est. Completion | 2032-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01904188
The ClinicalTrials.gov registry entry for NCT01904188 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 2,500 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,537-participant average among 90 other Sepsis trials with a reported enrollment target (62% lower). The listed sponsor is Michigan State University, which has 120 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Sepsis appearing as the primary indexed condition, and to 1 intervention - of which 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) is the first listed.
NCT01904188 reports 2 study locations spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT01904188 about?
NCT01904188 is a clinical study titled "Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?". 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 infe...
What is the current status of trial NCT01904188?
This trial is currently recruiting. The enrollment target is 2,500 participants. The study started on 2015-06. Estimated completion is 2032-07.
What conditions does trial NCT01904188 study?
This clinical trial studies the following conditions: Sepsis, Systemic Inflammatory Response Syndrome, Infection, Bacterial, Infection, Coronavirus, Infection Mixed.
What interventions are being tested in trial NCT01904188?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT01904188?
This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01904188 being conducted?
This trial has 2 study locations across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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