RecruitingNCT04878549

Transcriptomic Responses for the Identification of Pathogens

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


Sponsor

University of Sheffield

Enrollment

2,000 participants

Start Date

May 2, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 5-gene transcription signature for people with acute febrile illness, enteric fever, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST5-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.


Locations(1)

Christian Medical Centre

Vellore, India

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NCT04878549


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