InfectionsBEDSNCT07796945
Human Neutrophil Lipocalin as an Aid in the Diagnosis of Bacterial Infection in the Emergency Department
An observational study of Infections and Infections - Bacterial, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The aim of this study is to improve the medical care of patients with infections for which the cause cannot be clearly identified as bacterial or viral. To achieve this, we are investigating a new inflammatory marker in the blood that may help identify severe bacterial infections more quickly. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Infections - Bacterial, Viral Infection
- How many people
- 516 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 May 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency department patients with significant physiologic disturbance and signs and symptoms compatible with an infective illness, including the most common causes of sepsis
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: Human Neutrophil Lipocalin as an Aid in the Diagnosis of Bacterial Infection in the Emergency Department Basel Early Diagnosis of Sepsis (BEDS)
The aim of this study is to improve the medical care of patients with infections for which the cause cannot be clearly identified as bacterial or viral. To achieve this, we are investigating a new inflammatory marker in the blood that may help identify severe bacterial infections more quickly. Early detection is important to prevent complications and ensure that patients receive the most appropriate treatment as soon as possible.
This is an observational study. The knowledge gained from this study may help improve the care of patients with infections of unclear origin by supporting faster diagnosis, earlier treatment, improved risk assessment, and better planning of follow-up care.
Read the detailed description
This observational study evaluates the diagnostic and prognostic value of Human Neutrophil Lipocalin (HNL) in patients presenting to the Emergency Department (ED) with suspected infection.
Early identification of bacterial infection and sepsis remains a major challenge in emergency care due to the heterogeneity of clinical presentations and the lack of highly accurate diagnostic tools. In particular, distinguishing patients at low risk from those at risk of clinical deterioration is crucial for appropriate treatment decisions, triage, and disposition planning. Delayed recognition of bacterial infection and sepsis is associated with adverse outcomes, especially in patients with atypical presentations.
HNL has emerged as a promising biomarker for differentiating bacterial from viral infections. Previous studies have demonstrated a high diagnostic accuracy of HNL, with reported sensitivity and specificity exceeding 90%, potentially outperforming routinely used biomarkers such as white blood cell count (WBC) and C-reactive protein (CRP). A rapid and reliable biomarker for identifying bacterial infection could support earlier diagnosis, optimize patient management, reduce progression to sepsis, and contribute to more appropriate antibiotic use.
The primary objective of this study is to assess the diagnostic performance of HNL for the detection of bacterial infection in ED patients and to compare its accuracy with routinely used biomarkers, including WBC, CRP, and procalcitonin (PCT).
Secondary objectives include: Comparing the diagnostic performance of HNL measured in serum versus activated Li-heparin whole blood. Evaluating factors that may influence the predictive value of HNL, including age, sex, comorbidities, immunosuppression, and antibiotic treatment. Assessing the prognostic value of HNL for 30-day mortality and comparing its performance with serum lactate, an established predictor of adverse outcomes.
The results of this study may contribute to improved risk stratification and clinical decision-making in patients presenting to the ED with suspected infection.
- Conditions
- Infections, Infections - Bacterial, Viral Infection, Sepsis
- Keywords
- Sepsis, Emergency department, Early diagnosis of sepsis, Human neutrophil lipocalin, Biomarker, HNL
- Medical subject headings
- Infections, Bacterial Infections, Virus Diseases, Sepsis, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic Curve (AUROC) for bacterial infection
Diagnostic performance of HNL, WBC, CRP and PCT measured in venous blood samples collected at Emergency Department screening for identifying bacterial infection. Final infection classification (bacterial, viral, other infection, or no infection) will be determined by an independent adjudication committee based on clinical records, laboratory results and microbiological findings.
Measured: Baseline blood sample; diagnosis adjudicated after completion of follow-up (up to 30 days)
Sensitivity for bacterial infection
Sensitivity of HNL, WBC, CRP and PCT for identifying bacterial infection using the adjudicated infection diagnosis as the reference standard.
Measured: Baseline blood sample; diagnosis adjudicated after completion of follow-up (up to 30 days)
Specificity for sepsis and septic shock
Specificity of HNL, WBC, CRP and PCT for identifying sepsis and septic shock using adjudicated Sepsis-3 diagnoses as the reference standard.
Measured: Baseline blood sample; diagnosis adjudicated after completion of follow-up (up to 30 days)
Secondary outcomes (7)
30-day mortality
Death from any cause within 30 days after enrolment, assessed through follow-up contact with the patient's general practitioner, the patient or a relative, or other available sources.
Measured: 30 days after enrolment
Cause of death
Cause of death among participants who die during the 30-day follow-up period.
Measured: 30 days after enrolment
Hospital re-presentation
Re-presentation to hospital occurring within 30 days after enrolment.
Measured: 30 days after enrolment
Length of hospital stay (LOS)
Length of hospital stay for the index presentation, measured in days from admission to discharge.
Measured: From hospital admission to discharge, assessed up to 30 days after enrolment
Mortality in Emergency Department Sepsis (MEDS) score
Mortality in Emergency Department Sepsis (MEDS) score is a clinical risk stratification tool used to estimate the risk of mortality in patients with sepsis presenting to the emergency department. The total score ranges from 0 to 27 points, with higher scores indicating a greater predicted risk of death and a worse clinical prognosis.
Measured: Baseline (at Emergency Department presentation)
Sequential Organ Failure Assessment (SOFA) score
Sequential Organ Failure Assessment (SOFA) score is used to assess the extent of organ dysfunction across six organ systems (respiratory, cardiovascular, hepatic, coagulation, renal, and neurological). Total scores range from 0 to 24, with higher scores indicating more severe organ dysfunction and a worse clinical condition.
Measured: Baseline (at Emergency Department presentation)
Quick Sequential Organ Failure Assessment (qSOFA) score
The Quick Sequential Organ Failure Assessment (qSOFA) score is a bedside screening tool used to identify patients with suspected infection who are at increased risk of poor outcomes. The total score ranges from 0 to 3 points, based on altered mental status, systolic blood pressure ≤100 mmHg, and respiratory rate ≥22 breaths per minute. Higher scores indicate a greater risk of adverse outcomes and a worse clinical prognosis.
Measured: Baseline (at Emergency Department presentation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start5 May 2017
- Primary completion31 May 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Roland Bingisser, Principal investigator, Prof. Dr. med.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796945
- Sponsor's protocol ID
- 2017-0092; me16bingisser2
- Acronym
- BEDS
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Neutrophil Lipocalin as an Aid in the Diagnosis of Bacterial Infection in the Emergency Department Basel Early Diagnosis of Sepsis (BEDS)
- ClinicalTrials.gov ID
- NCT07796945
- Acronym / sponsor ID
- BEDS / 2017-0092; me16bingisser2
- Conditions
- Infections, Infections - Bacterial, Viral Infection, Sepsis
- Keywords
- Sepsis, Emergency department, Early diagnosis of sepsis, Human neutrophil lipocalin, Biomarker, HNL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Clinical Trial Unit, University Hospital Basel, Switzerland
- Study start
- 5 May 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to improve the medical care of patients with infections for which the cause cannot be clearly identified as bacterial or viral. To achieve this, we are investigating a new inflammatory marker in the blood that may help identify severe bacterial infections more quickly. Early detection is important to prevent complications and ensure that patients receive the most appropriate treatment as soon as possible.
This is an observational study. The knowledge gained from this study may help improve the care of patients with infections of unclear origin by supporting faster diagnosis, earlier treatment, improved risk assessment, and better planning of follow-up care.
Detailed description
This observational study evaluates the diagnostic and prognostic value of Human Neutrophil Lipocalin (HNL) in patients presenting to the Emergency Department (ED) with suspected infection.
Early identification of bacterial infection and sepsis remains a major challenge in emergency care due to the heterogeneity of clinical presentations and the lack of highly accurate diagnostic tools. In particular, distinguishing patients at low risk from those at risk of clinical deterioration is crucial for appropriate treatment decisions, triage, and disposition planning. Delayed recognition of bacterial infection and sepsis is associated with adverse outcomes, especially in patients with atypical presentations.
HNL has emerged as a promising biomarker for differentiating bacterial from viral infections. Previous studies have demonstrated a high diagnostic accuracy of HNL, with reported sensitivity and specificity exceeding 90%, potentially outperforming routinely used biomarkers such as white blood cell count (WBC) and C-reactive protein (CRP). A rapid and reliable biomarker for identifying bacterial infection could support earlier diagnosis, optimize patient management, reduce progression to sepsis, and contribute to more appropriate antibiotic use.
The primary objective of this study is to assess the diagnostic performance of HNL for the detection of bacterial infection in ED patients and to compare its accuracy with routinely used biomarkers, including WBC, CRP, and procalcitonin (PCT).
Secondary objectives include: Comparing the diagnostic performance of HNL measured in serum versus activated Li-heparin whole blood. Evaluating factors that may influence the predictive value of HNL, including age, sex, comorbidities, immunosuppression, and antibiotic treatment. Assessing the prognostic value of HNL for 30-day mortality and comparing its performance with serum lactate, an established predictor of adverse outcomes.
The results of this study may contribute to improved risk stratification and clinical decision-making in patients presenting to the ED with suspected infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency department patients with significant physiologic disturbance and signs and symptoms compatible with an infective illness, including the most common causes of sepsis
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area Under the Receiver Operating Characteristic Curve (AUROC) for bacterial infection
Time frame: Baseline blood sample; diagnosis adjudicated after completion of follow-up (up to 30 days)
Diagnostic performance of HNL, WBC, CRP and PCT measured in venous blood samples collected at Emergency Department screening for identifying bacterial infection. Final infection classification (bacterial, viral, other infection, or no infection) will be determined by an independent adjudication committee based on clinical records, laboratory results and microbiological findings.
Sensitivity for bacterial infection
Time frame: Baseline blood sample; diagnosis adjudicated after completion of follow-up (up to 30 days)
Sensitivity of HNL, WBC, CRP and PCT for identifying bacterial infection using the adjudicated infection diagnosis as the reference standard.
Specificity for sepsis and septic shock
Time frame: Baseline blood sample; diagnosis adjudicated after completion of follow-up (up to 30 days)
Specificity of HNL, WBC, CRP and PCT for identifying sepsis and septic shock using adjudicated Sepsis-3 diagnoses as the reference standard.
7 secondary outcomes
30-day mortality
Time frame: 30 days after enrolment
Cause of death
Time frame: 30 days after enrolment
Hospital re-presentation
Time frame: 30 days after enrolment
Length of hospital stay (LOS)
Time frame: From hospital admission to discharge, assessed up to 30 days after enrolment
Mortality in Emergency Department Sepsis (MEDS) score
Time frame: Baseline (at Emergency Department presentation)
Sequential Organ Failure Assessment (SOFA) score
Time frame: Baseline (at Emergency Department presentation)
Quick Sequential Organ Failure Assessment (qSOFA) score
Time frame: Baseline (at Emergency Department presentation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland Bingisser principal investigator
Prof. Dr. med.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infections and Infections - Bacterial, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic Curve (AUROC) for bacterial infection (time frame: Baseline blood sample; diagnosis adjudicated after completion of follow-up (up to 30 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.