Transcriptomic Responses for the Identification of Pathogens

Recruiting

• Conditions: Typhoid; Enteric Fever; Acute Febrile Illness; Fever; Paratyphoid Fever
• Interventions: Diagnostic Test: 5-gene transcription signature

• Registration Number: NCT04878549
• Lead Sponsor: University of Sheffield

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-07
• Study Start: 2022-05-02
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-03
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	5-gene transcription signature	400 afebrile, healthy adult participants (15 to 45 years old).
Febrile Adults	5-gene transcription signature	1200 adult participants (15 to 45 years old) with a febrile illness without localising features and reported duration of 3-14 days.
Febrile Children	5-gene transcription signature	400 child participants (2 to 14 years old) with a febrile illness without localising features and reported duration of 3-14 days. This is an exploratory arm of the study.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity (AUROC) of a diagnostic score derived from transcriptional responses by a 5-gene transcription signature (STAT1, SLAMF8, PSME2, WARS, ALDH1A1) in classifying patients with blood culture-confirmed enteric fever.	2.5 years	Evaluate the performance of a host gene transcription signature for detecting enteric fever in adults presenting with acute undifferentiated fever (AUFI)

Secondary Outcome Measures

Name	Time	Method
Number of participants with diagnosis confirmed by laboratory testing.	2.5 years	Determine the frequency of other common causes of AUFI at each site.
Number of participants presenting with mild, moderate or severe illness by clinical diagnosis according to validated prognostic scores such as sepsis scoring systems.	2.5 years	Assess the relationship between markers of clinical illness severity, likely infection cause and level of molecular perturbation.

Trial Locations

Locations (1)

Christian Medical Centre; 🇮🇳 Vellore, India