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A drop of blood, a faster answer: new test aims to outpace sepsis in preterm infants

NCT ID NCT07774013

Diagnosis Sponsor: Medical University of Graz Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This pilot study is testing whether a rapid, point-of-care blood test can help identify early signs of infection and sepsis in preterm infants. Researchers will measure inflammatory markers like IL-6, PCT, CRP, and MxA in blood samples from about 40 to 80 premature babies, comparing the device's results with standard lab tests. The goal is to see if this faster method can detect infections earlier and even help tell bacterial from viral infections, without changing the infants' routine care.

What this could mean

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

Active substance
Point-of-care measurement of inflammatory biomarkers (IL-6, PCT, CRP, MxA) using the AFIAS-3 device
What this could lead to
If successful, this could enable faster, bedside detection of sepsis in preterm infants, potentially leading to earlier treatment and better outcomes.
What could go wrong
This is a small pilot study, so results may not be definitive. The point-of-care device may not match lab accuracy, and the study does not change treatment decisions.

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 80 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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

The study population consists of preterm neonates born at less than 37+0 weeks of gestation who are admitted to the Division of Neonatology, Department of Pediatrics, Medical University of Graz after birth and have a clinical suspicion of infection. Eligible infants are enrolled prospectively before their sepsis status is established. Participants are subsequently classified into an infection/sepsis group or a control group according to predefined diagnostic criteria. Approximately 40 preterm neonates are expected to be included, with an overall maximum of 80 participants.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Preterm neonates born at \<37+0 weeks of gestation who are admitted to the Division of Neonatology, Department of Pediatrics, Medical University of Graz after birth. * Written parental informed consent before birth. Exclusion Criteria: * Term and preterm neonates who are not admitted to the neonatal care unit. * No point-of-care measurement of IL-6 and PCT in neonatal blood for infants who do not require blood gas analysis within the first 12 hours of life.

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Conditions

The condition(s) this trial relates to.

familial porphyria cutanea tarda infectious disease with sepsis neonatal sepsis Sepsis

As listed by the trial registrant

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

IL6 Neonate PCT Point of care Sepsis

How to take part

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  1. The places running it

    1 site. 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

  • Medical University Graz

    Graz, Styria, 8034, Austria

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