NCT04878549

Transcriptomic Responses for the Identification of Pathogens

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: University of Sheffield · Academic / Other
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Acute undifferentiated febrile infection (AUFI) is a common presenting syndrome in low-resource settings and better diagnostics are urgently needed to improve patient management and guide disease prevention interventions. Assessment of the host gene expression response to infection in endemic populations has demonstrated significant promise as a new approach to identifying patients with enteric fever and for potential in differentiating between other causes of AUFI. Signatures identified through new data analytic techniques could be developed into a point-of-care test for use in endemic settings. In this multisite diagnostic evaluation study we will collect prospective clinical, laboratory and diagnostic data from two endemic settings to evaluate host gene expression signatures for detecting enteric fever and for determining the cause of AUFI in LMIC settings.

Conditions

• Enteric Fever
• Acute Febrile Illness
• Typhoid
• Paratyphoid Fever
• Fever

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	5-gene transcription signature	This is a prospective multisite diagnostic evaluation study to assess a novel approach to the diagnosis of enteric fever. The index test of host gene transcription responses by a 5 gene-signature will be compared to the reference test of blood culture confirmation for a diagnosis of enteric fever in patients with AUFI.

Timeline

• Start date: 2022-05-02
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2021-05-07
• Last updated: 2025-03-03

Locations

1 site across 1 country: India