Transcriptomic Responses for the Identification of Pathogens

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-65
SponsorUniversity of Sheffield

About this trial

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 criteria

Qualifiers

Participant is willing and they and/or an appropriate guardian/relative/representative is able to give informed consent for participation in the study and a follow-up (telephone) discussion at 14 days

Febrile illness without localising features (see '

Disqualifiers

documented tympanic/rectal temperature of ≥ 38°C or an axillary/oral temperature of ≥ 37.8°C, or a reported fever within the last 24 hours and

Reported duration of fever 3-14 days or

Recently confirmed blood culture indicating enteric fever (confirmed within the previous 5 days)

They may have had recent exposure to antimicrobials.

Trial design

Treatments tested in this trial

  • 5-gene transcription signature

Treatment groups

2,000 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University of Sheffield

Lead sponsor

Christian Medical College, Vellore, India

Collaborator

KEMRI-Wellcome Trust Collaborative Research Program

Collaborator