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Transcriptomic Responses for the Identification of Pathogens

NCT04878549 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2025-03-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Christian Medical College, Vellore, India

    collaborator OTHER

  • KEMRI-Wellcome Trust Collaborative Research Program

    collaborator OTHER

  • University of Sheffield

    lead OTHER

Principal Investigators

  • Thomas Darton · University of Sheffield

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-02
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04878549 on ClinicalTrials.gov