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

NCT ID: NCT07205575

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 394 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-11-30

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.

Detailed Description

This study aims to identify and validate proteomics-based diagnostic biomarkers for differentiating bacterial from viral acute febrile illnesses. It is conducted on the same patient cohort previously used in a registered transcriptomic biomarker study (ClinicalTrials.gov Identifier: NCT065529754).

Although both studies share the overarching clinical objective of improving infection triage, they are scientifically independent in terms of methodology, biomarker modality, and analytical pipeline. Transcriptomic study (NCT065529754): Focused on host-response gene expression signatures derived from RNA sequencing data. Proteomic study (this registration): Focuses on host-response protein biomarkers identified through high-resolution mass spectrometry (DIA/PRM/SRM) and validated by immunoassays (ELISA).

The proteomics study is designed to discover a minimal and biologically distinct set of protein markers that can be readily translated into clinical diagnostics. This study evaluates a minimal set of circulating proteins-ICAM1, CFHR5, and GRN-discovered through AI-assisted proteomics and validated by ELISA, as a rapid diagnostic tool for bacterial vs viral infection. Patients with acute fever are prospectively enrolled into three cohorts: discovery, internal validation, and external validation.

This independent registration reflects the proteomics-specific objectives, methodology, and outcomes, while also acknowledging its linkage to the transcriptomics study.

Conditions

Acute Febrile Illness; Bacterial Infections; Viral Infections; Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Bacterial infections

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

Proteomic Biomarker Panel

Intervention Type: 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.

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).

Proteomic Biomarker Panel

Intervention Type: 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.

Interventions

Proteomic Biomarker Panel

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Gang Wang, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qilu Hospital of Shandong University

Jinan, Shandong, China

Countries

China

Other Identifiers

2021SDUCRCC004

Identifier Type: OTHER

Identifier Source: secondary_id

KYLL-202008-058-P

Identifier Type: -

Identifier Source: org_study_id