A Multisite Evaluation of Functional Genomic Signatures for the Improved Diagnosis of Acute Undifferentiated Febrile Infections

What this Trial Is About

Researchers are evaluating new diagnostic methods to improve detection of enteric fever and other causes of acute undifferentiated febrile infections (AUFI) in low-resource settings. This observational study aims to assess host gene expression signatures to better identify patients with enteric fever and distinguish it from other febrile illnesses. The study is conducted in multiple endemic locations to gather clinical and laboratory data that can help develop a point-of-care test for these infections. The study includes three groups: 1200 adults aged 15 to 65 years with febrile illness lasting 3 to 14 days without clear localizing symptoms, 400 healthy adults without fever aged 15 to 65 years, and an exploratory group of 400 children aged 2 to 14 years with similar febrile illness. The main diagnostic test being studied is a 5-gene transcription signature compared against blood culture confirmation for enteric fever. Participants are assessed across these groups to evaluate the accuracy of this gene expression test. Participants will provide clinical information and biological samples over a period of 2.5 years to measure transcriptional responses and confirm diagnoses. Researchers will track illness severity using clinical scoring systems and laboratory confirmation. The primary outcome is the sensitivity and specificity of the gene signature test in identifying enteric fever. Secondary outcomes include the number of cases confirmed by laboratory testing and illness severity classification. The study also includes follow-up discussions 14 days after enrollment to gather additional information.

Transcriptomic Responses for the Identification of Pathogens