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DNA test for infections: can it guide antibiotic decisions?

NCT ID NCT07825714

Diagnosis Sponsor: Karius, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are running a large observational registry to see how a blood test called metagenomic sequencing is used in routine care for people with or at risk of serious infections, including those with weakened immune systems. The study enrolls participants at multiple hospitals and clinics without assigning any treatment or changing their standard care. It collects information from routine visits, such as test results, antibiotic use, and health outcomes, to understand whether and how the sequencing test informs doctors' decisions. The goal is to learn how this test fits into real-world infection management and whether it helps guide treatment.

What this could mean

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

Active substance
metagenomic sequencing of blood to detect infection-causing microbes
What this could lead to
If the approach proves useful, doctors could get faster, more precise information about which microbes are causing an infection, which may help them adjust antibiotics sooner and improve care for people with weakened immune systems.
What could go wrong
This is an observational registry, not a controlled experiment, so it cannot prove that sequencing causes better outcomes. Results may be confounded by differences in patients and care settings, and the findings may not apply everywhere.

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 10,000 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Participants receiving routine clinical care at participating institutions who meet eligibility criteria for one or more active AXIS cohorts. Cohorts may evaluate metagenomic sequencing for diagnostic evaluation, surveillance, or longitudinal monitoring across a range of infectious disease syndromes, patient populations, and healthcare settings. This approach prevents you from having to amend the NCT record every time AXIS expands beyond hospitalized immunocompromised patients with lower respiratory infections. It also aligns with how platform registries and master protocols are typically registered.

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: * Participant receives care at a participating AXIS site. * Participant meets eligibility criteria for at least one active AXIS cohort as defined in the applicable cohort appendix. * Participant or legally authorized representative is able to provide informed consent, unless waived by the reviewing IRB. Exclusion Criteria: * Any condition that, in the opinion of the investigator, would make participation inappropriate or prevent completion of required study procedures. * Additional cohort-specific exclusion criteria may apply and are defined within the applicable cohort appendix.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid system neoplasm infectious disease Opportunistic Infections opportunistic infectious

As listed by the trial registrant

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

Immunocompromised host Infectious diseases Opportunistic infections

How to take part

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  1. 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 ↗

  2. 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.

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