Viral Infection / Infections Bacterial / Infections · Observational Study

Human Neutrophil Lipocalin as an Aid in the Diagnosis of Bacterial Infection in the Emergency Department

ClinicalTrials.gov · September 1, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed observational study registered to evaluate neutrophil lipocalin as a diagnostic marker for bacterial infection in the emergency department. No results are reported in this registry record; the source describes study design and planned outcome measures only.

What was studied

Observational. Infections, Infections - Bacterial, Viral Infection, Sepsis; age from 18 Years. Intervention: Baseline neutrophil lipocalin measurement (blood sample). n = 516. 1 site: Switzerland.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a completed observational registry study with no results posted; the source describes study design and planned analyses only, without outcome data.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: Area Under the Receiver Operating Characteristic Curve (AUROC) for bacterial infection (assessed at Baseline blood sample; diagnosis adjudicated after completion of follow-up (up…); Sensitivity for bacterial infection (assessed at Baseline blood sample; diagnosis adjudicated after completion of follow-up (up…); Specificity for sepsis and septic shock (assessed at Baseline blood sample; diagnosis adjudicated after completion of follow-up (up…)

DesignObservational

PopulationInfections, Infections - Bacterial, Viral Infection, Sepsis; age from 18 Years

Sample size516

InterventionBaseline neutrophil lipocalin measurement (blood sample)

Setting1 site: Switzerland

Reported figures

Quoted from the source exactly as published.

Sample size516

Primary outcome measure 1Area Under the Receiver Operating Characteristic Curve (AUROC) for bacterial infection

Primary outcome measure 2Sensitivity for bacterial infection

Primary outcome measure 3Specificity for sepsis and septic shock

Follow-up durationup to 30 days

Caveats

This is a registry record; no results are reported.
No outcome data, effect sizes, or statistical comparisons are available in this source.
Study site (University Hospital, Basel, Switzerland) suggests single-center design; generalizability not addressed.
Diagnostic adjudication method and blinding status not disclosed in registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational design; no randomization or control arm specified.

Directness

moderate

Diagnostic accuracy outcomes (AUROC, sensitivity, specificity) directly measure test performance.

Consistency

insufficient

Single-site observational study; no comparison data or replication reported.

Risk of bias

insufficient

Registry record does not disclose blinding, adjudication methods, or bias mitigation detail.

Sample adequacy

moderate

516 participants enrolled; adequacy for diagnostic accuracy depends on event rates not stated.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07796945). This is a study registration, not published results. Lead sponsor: University Hospital, Basel, Switzerland. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 516 participants (ACTUAL). Conditions: Infections, Infections - Bacterial, Viral Infection, Sepsis. Primary outcome measures: Area Under the Receiver Operating Characteristic Curve (AUROC) for bacterial infection , Baseline blood sample; diagnosis adjudicated after completion of follow-up (up to 30 days); Sensitivity for bacterial infection , Baseline blood sample; diagnosis adjudicated after completion of follow-up (up to 30 days); Specificity for sepsis and septic shock , Baseline blood sample; diagnosis adjudicated after completion of follow-up (up to 30 days). Brief 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. 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.

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Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Viral InfectionNCT07796945Infections BacterialUniversity Hospital, Basel, SwitzerlandInfections