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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: Recruiting study of Sepsis and Systemic Inflammatory Response Syndrome, sponsored by Michigan State University.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Frozen microbial specimens will be transported to an off site laboratory for analysis with the GeneZ or other point of care or rapid diagnostic technique or device, with investigators blinded to the final culture results of the specimen - positive or negative. Comparison will be made between final culture result and GeneZ identification of organism or other method as developed in the investigators' lab.

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

FieldValue
Enrollment Target 2,500 participants
Start Date 2015-06
Est. Completion 2032-07
Michigan State University

120 total trials

What NCT01904188 shows while recruiting

NCT01904188 is an observational study that tracks outcomes without assigning an intervention. Its 2,500 participants enrollment target places it among the larger protocols in the corpus, below the 6,537-participant average among 90 other Sepsis trials with a reported enrollment target (62% lower).

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 a single indexed study location in 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.

Similar trials for Sepsis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01904188's enrollment target sits among peer trials

2,500 13th of 90 higher than 78 of 90 other Sepsis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Sepsis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01904188, the US trial registry maintained by the National Library of Medicine. NCT01904188 (large enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.