An observational study in Infections, Infections - Bacterial and Viral Infection, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by University Hospital, Basel, Switzerland · Observational
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.
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.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's enrollment of 516 is above the median of 300 across 685 observational studies indexed under Infections.
Browse Infections studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
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Emergency department patients with significant physiologic disturbance and signs and symptoms compatible with an infective illness, including the most common causes of sepsis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline blood sample; diagnosis adjudicated after completion of follow-up (up to 30 days)
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.
Time frame: 30 days after enrolment
Cause of death
Cause of death among participants who die during the 30-day follow-up period.
Time frame: 30 days after enrolment
Hospital re-presentation
Re-presentation to hospital occurring within 30 days after enrolment.
Time frame: 30 days after enrolment
Length of hospital stay (LOS)
Length of hospital stay for the index presentation, measured in days from admission to discharge.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (at Emergency Department presentation)
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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