Diagnostic biomarker for acute febrile illness
Transcriptome-based Diagnostic Biomarker for Acute Febrile Illness: a Cross-sectional Observational Study
This study is testing a new way to quickly tell if a fever is caused by a bacterial or viral infection to help patients get the right treatment faster.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06552975 on ClinicalTrials.gov |
What this trial studies
This study investigates a transcriptome-based diagnostic biomarker aimed at distinguishing between bacterial and viral infections in patients with acute febrile illness. By analyzing host gene expression in response to infections, the study seeks to provide a rapid and accurate diagnostic tool that could reduce reliance on traditional methods, which are often slow and prone to errors. The research focuses on developing a cost-effective approach that can be implemented even in under-resourced healthcare settings. The ultimate goal is to improve patient outcomes by enabling timely and appropriate treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with a fever of 38°C or higher lasting less than 14 days who are willing to participate.
Not a fit: Patients with comorbidities affecting gene expression, those who are pregnant, or individuals with mixed infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses and reduce unnecessary antibiotic use, thereby improving patient care and combating antibiotic resistance.
How similar studies have performed: While the use of transcriptome analysis in diagnostics is promising, this specific approach to acute febrile illness is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. 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. Exclusion Criteria: * 1.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.
Where this trial is running
Jinan, Shandong
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Gang Wang, professor
- Email: wangg1975@hotmail.com
- Phone: 86-18560082130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.