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Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?
NCT01904188 · View on ClinicalTrials.gov ↗
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. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michigan State University, which has 134 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01904188 reports 2 study locations spanning 1 distinct geographic area — top geographies include Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01904188?
This trial is sponsored by Michigan State University, which has 134 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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