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New rapid test could speed up sepsis diagnosis in ER

NCT ID NCT01904188

Knowledge-focused Sponsor: Michigan State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new rapid diagnostic device called In-Dx to quickly identify infections and antibiotic resistance in emergency patients with suspected sepsis. Researchers will compare the device's results to standard lab cultures using stored samples from 2,500 patients. The goal is to see if the device can provide accurate results faster, but it will not affect current patient care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
In-Dx rapid diagnostic device
What this could lead to
If successful, this could lead to faster, more accurate identification of infections and antibiotic resistance, potentially improving sepsis treatment.
What could go wrong
This is an early-stage diagnostic study that does not change patient care yet. The device may not be accurate enough or may not work in real-world settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,500 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Jun 2015

Expected to finish

Jul 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients who undergo evaluation for suspected sepsis who have peripheral blood cultures and/or urine samples obtained and patient characteristics recorded. In addition those that have an obvious infection without sepsis will be consented. Those that have other bodily fluids involved in addition will also be included, with or without SIRS criteria. (Sputum, wound drainage, CSF, oral or nasal secretions).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease coinfection Coronavinae infectious disease fungal infectious disease infectious disease infectious disease with sepsis Orthocoronavirinae infectious disease Sepsis Systemic Inflammatory Response Syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antibiotic resistance genes Human genome analysis Infection mixed Infection, bacterial Infection, coronavirus Infection, fungal Sepsis Systemic inflammatory response syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • McLaren Greater Lansing

    RECRUITING

    Lansing, Michigan, 48910, United States

  • University of Michigan Health/Sparrow (name change only)

    RECRUITING

    Lansing, Michigan, 48909, United States

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