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A simple blood test may spot severe bacterial infections faster in the ER

NCT ID NCT07796945

Diagnosis Sponsor: University Hospital, Basel, Switzerland 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

Researchers in Basel are testing whether a blood marker called HNL can help emergency doctors quickly tell whether an infection is bacterial or viral. The study will enroll about 516 adults with suspected infection and signs of physiological disturbance. Doctors will measure HNL alongside standard markers like white blood cell count, CRP, and PCT, then compare the results against a final diagnosis made by an independent committee. The goal is to see if HNL improves early detection of bacterial infection and sepsis, which could speed up treatment and reduce complications.

What this could mean

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

Active substance
A blood test measuring the inflammatory marker HNL (human neutrophil lipocalin), compared with standard markers like white blood cell count, CRP, and PCT.
What this could lead to
If HNL proves accurate, emergency doctors could identify bacterial infections and sepsis sooner, leading to faster treatment and better patient outcomes.
What could go wrong
This is an observational study, so it cannot prove HNL improves outcomes directly. The marker may not perform better than existing tests, and results depend on how accurately infections are classified.

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

516 people

The number who actually took part.

Started

May 2017

Finished

Dec 2018

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

Emergency department patients with significant physiologic disturbance and signs and symptoms compatible with an infective illness, including the most common causes of sepsis

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: * Adults presenting to the Emergency Department with suspected infection * Written informed consent provided prior to enrolment * Evidence of significant physiological disturbance, defined by abnormal vital signs requiring further medical assessment * Symptoms suggestive of a respiratory tract infection (e.g. cough with sputum, worsening cough, or breathing difficulties) * Symptoms suggestive of a urinary tract infection (e.g. pain during urination, frequent urination, or urgency) * Pain, redness, warmth, or discharge at the site of a vascular catheter or intravenous line * Signs of a skin or soft tissue infection, including pain, tenderness, swelling, redness, warmth, or pus formation * Nausea, vomiting, abdominal pain, or jaundice suggestive of a possible abdominal infection * Headache, neck stiffness, or other symptoms suggestive of a central nervous system infection * Abnormal vital signs corresponding to a National Early Warning Score (NEWS) of ≥3 points Exclusion Criteria: * Known pregnancy at the time of study enrolment * Antibiotic treatment that started more than 24 hours before presentation to the Emergency Department * Inability or unwillingness to provide written informed consent for study participation

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Conditions

The condition(s) this trial relates to.

bacterial infectious disease Emergencies Infections infectious disease infectious disease with sepsis Sepsis viral infectious disease

As listed by the trial registrant

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

Infections Infections - bacterial Sepsis Viral infection

Contacts and locations

Locations

  • University Hospital Basel

    Basel, Canton of Basel-City, 4031, Switzerland

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