Acute Febrile IllnessNCT07205575
AI-Guided Proteomic Biomarker Panel for Differentiating Bacterial and Viral Infections in Acute Febrile Illness
An observational study of Acute Febrile Illness and Bacterial Infections, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Acute Febrile Illness, Bacterial Infections, Viral Infections
- What is being tested?
- Proteomic Biomarker Panel
- How many people
- 394 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 30 Nov 2024
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AI-Guided Proteomic Discovery and Multi-Cohort Validation of a Circulative Protein Signature to Differentiate Bacterial and Viral Infections in Acute Febrile Illness
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.
Read the 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
- Being tested
- Proteomic Biomarker Panel
- Medical subject headings
- Bacterial Infections, Virus Diseases, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proteomic Biomarker PanelDiagnostic test
A blood-based ELISA test measuring circulating ICAM1, CFHR5, and GRN. Index test performance will be evaluated against microbiological gold standards and adjudication.
| Study group | Role | What they receive |
|---|---|---|
| Bacterial infections | Individuals with acute fever whose positive bacteria isolated from sterile or non-sterile sites have pathological characteristics. Receives: 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). Receives: Diagnostic Test: Proteomic Biomarker Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Evaluate the increase in area under the receiver operating characteristic curve (AUROC) when the host-response protein biomarker panel is combined with CRP for distinguishing bacterial from viral infections.
Measured: 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
Assess the ability of the biomarker panel to predict clinical disease severity in patients with acute febrile illness, as measured by the qSOFA score.
Measured: 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
Measured: At hospital admission (retrospective review of cases from September 1, 2021 to October 31, 2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Sep 2021
- Primary completion31 Oct 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Febrile IllnessStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Cross-sectional
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gang Wang, MD, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205575
- Sponsor's protocol ID
- KYLL-202008-058-P
- Other IDs
- 2021SDUCRCC004
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant-level clinical data and proteomic assay data generated from plasma samples will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-Guided Proteomic Discovery and Multi-Cohort Validation of a Circulative Protein Signature to Differentiate Bacterial and Viral Infections in Acute Febrile Illness
- ClinicalTrials.gov ID
- NCT07205575
- Acronym / sponsor ID
- KYLL-202008-058-P
- Conditions
- Acute Febrile Illness, Bacterial Infections, Viral Infections, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 3 Oct 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacterial infections | – | Diagnostic Test: Proteomic Biomarker PanelIndividuals with acute fever whose positive bacteria isolated from sterile or non-sterile sites have pathological characteristics. |
| Viral infections | – | Diagnostic Test: Proteomic Biomarker PanelGroup/Cohort Description: Individuals with acute fever whose viral nucleic acid test and/or serological positive compatible with acute syndrome#(e.g. serology, PCR). |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proteomic Biomarker PanelA blood-based ELISA test measuring circulating ICAM1, CFHR5, and GRN. Index test performance will be evaluated against microbiological gold standards and adjudication. | Diagnostic test | Bacterial infections, Viral infections |
Primary outcome
Diagnostic Accuracy (AUROC) for differentiating bacterial vs viral infection
Time frame: At hospital admission (retrospective review of cases from September 1, 2021 to October 31, 2024)
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.
3 secondary outcomes
Incremental diagnostic value of biomarker panel combined with CRP
Time frame: 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
Time frame: 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
Time frame: At hospital admission (retrospective review of cases from September 1, 2021 to October 31, 2024)
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 3 Oct 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant-level clinical data and proteomic assay data generated from plasma samples will be shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Febrile Illness and Bacterial Infections, run by Qilu Hospital of Shandong University at 1 site in China.
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 4 inclusion and 5 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 3 Oct 2025. 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 China. 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?
Diagnostic Accuracy (AUROC) for differentiating bacterial vs viral infection (time frame: At hospital admission (retrospective review of cases from September 1, 2021 to October 31, 2024)). 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 3 Oct 2025.