Clinical Study of Transcriptome-based Diagnostic Biomarker for Acute Febrile Illness

NCT06552975 | Unknown

• 1 other identifier: KYLL-202008-058
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

Acute febrile illness is the main cause of outpatient visits，and bacterial and viral infections remains the most common cause. The diagnosis of infection is still based on symptoms and traditional techniques, resulting in overuse of antibacterial drugs or delay in treatment. The signature of host transcripts has a potential to reveal different modes of host-pathogen interaction and may serve as a biomarker for infection discrimination. Of note, transcriptome-microarray and RNA-seq methods need sophisticated techniques and expertise interpretation, hampering the universal implement of these platforms in low-tier hospitals and under- resourced countries. This study explores transcriptome-based diagnostic biomarker for acute febrile illness , hoping to achieve rapid, accurate and cost-effective distinction between bacterial and viral infection.

Conditions

Acute Febrile Illness

Keywords

Bacterial infection; Viral infection; noninfectious disease

Outcome Measures

Primary Outcomes (1)

• AUC for distinguishing bacterial infection from viral infection

  The AUC of the transcript biomarkers for distinguishing bacterial infection from viral infection reflects the diagnostic accuracy of the transcript biomarkers.

  Through study completion, an average of 2 years

Secondary Outcomes (1)

• AUC for distinguishing infectious disease from noninfectious disease

  Through study completion, an average of 2 years

Study Arms (3)

Bacterial infection

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

Other: Infection

Viral infection

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

Other: Infection

non-infectious group

Individuals with acute fever whose have negative findings in cultures and PCR; negative image modality findings suspected for infection; confirmed or highly likely other diagnosis; improvement without antibiotics.

Interventions

Infection OTHER

Pathogens such as bacteria and viruses invade the human body, grow, and proliferation, triggering an immune response.

Bacterial infection; Viral infection

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who have an axillary temperature of 38°C or higher, with a fever duration of less than 14 days.

You may qualify if:

• \. axillary temperature ≥38°C; 2. duration of fever shorter than 14 days; 3. subjects who are fully informed and agree to participate in this study.

You may not qualify if:

• having comorbidities that may affect host gene expression, such as advanced malignancy, autoimmune diseases，immunodeficiency, or taking immune suppressors; 2.pregnancy; 3. mixed infection (viral combined with bacterial infection, autoimmune disease combined with bacterial infection); 4.incomplete clinical information; 5. For safety reasons or the interests of patients, clinicians believe that patients should not participate in any situation in this study.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

2-3ml of peripheral blood samples collected by each patient were divided into two parts, one part was added with trizol for subsequent RT-PCR, and the other part was used for separating serum and detecting serum biomarker.

MeSH Terms

Conditions

Bacterial Infections; Virus Diseases; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gang Wang

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Gang Wang, professor

CONTACT

86-18560082130; wangg1975@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 14, 2024
• Study Start: September 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: August 30, 2025
• Last Updated: August 14, 2024

Record last verified: 2023-11

Locations

CN (1)