AI-Guided Proteomic Biomarker Panel for Differentiating Bacterial and Viral Infections in Acute Febrile Illness

NCT07205575 | Completed

• 2 other identifiers: KYLL-202008-058-P2021SDUCRCC004
• Study Type: observational
• Target: 394
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a proteomics-based diagnostic biomarker study conducted on the same patient cohort as the transcriptomic biomarker study (NCT065529754). Although both studies share the same clinical cohort and overarching diagnostic aim, they are registered separately because they employ distinct omics technologies, investigate different biomarker modalities, and yield independent outcome measures.

Conditions

Acute Febrile Illness; Bacterial Infections; Viral Infections; Sepsis

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy (AUROC) for differentiating bacterial vs viral infection

  The area under the receiver operating characteristic curve (AUROC) will be calculated for the selected host-response protein biomarker panel to assess its ability to discriminate bacterial from viral infections in patients presenting with acute febrile illness.

  At hospital admission (retrospective review of cases from September 1, 2021 to October 31, 2024)

Secondary Outcomes (3)

• Incremental diagnostic value of biomarker panel combined with CRP

  At hospital admission (retrospective review of cases from September 1, 2021 to October 31, 2024)

• Prognostic value for sepsis severity (qSOFA ≥2) and adverse outcomes

  At hospital admission (retrospective review of cases from September 1, 2021 to November 30, 2024)

• Sensitivity, specificity, PPV, NPV, LR+/LR- for differentiating bacterial vs viral infection

  At hospital admission (retrospective review of cases from September 1, 2021 to October 31, 2024)

Study Arms (2)

Bacterial infections

Individuals with acute fever whose positive bacteria isolated from sterile or non-sterile sites have pathological characteristics.

Diagnostic Test: Proteomic Biomarker Panel

Viral infections

Group/Cohort Description: Individuals with acute fever whose viral nucleic acid test and/or serological positive compatible with acute syndrome#(e.g. serology, PCR).

Diagnostic Test: Proteomic Biomarker Panel

Interventions

Proteomic Biomarker Panel DIAGNOSTIC_TEST

A blood-based ELISA test measuring circulating ICAM1, CFHR5, and GRN. Index test performance will be evaluated against microbiological gold standards and adjudication.

Bacterial infections; Viral infections

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 14 years or older who presented to the emergency department with acute febrile illness (fever ≤14 days, ≥38°C within 72 hours) and suspected bacterial or viral infection.

You may qualify if:

• Age ≥14 years；
• Body temperature \> 38°C(within the past 72 hours)；
• Disease duration ≤ 14 days；
• Provision of informed consent by patient or legal guardian.

You may not qualify if:

• Underlying diseases affecting immune function (e.g., advanced malignancy, autoimmune disease, immunodeficiency, use of immunosuppressants);
• Pregnancy;
• Mixed infections (including viral-bacterial co-infections, bacterial or viral-fungal co-infections, or autoimmune disease concomitant with bacterial infection);
• indeterminate or negative microbiological testing ;
• inability to provide informed consent

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Bacterial Infections; Virus Diseases; Sepsis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 3, 2025
• Study Start: September 1, 2021
• Primary Completion: October 31, 2024
• Study Completion: November 30, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Available after publication of primary results.
• Access Criteria: Researchers with approved proposals and signed data-sharing agreements.

Locations

CN (1)