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
Sponsors and collaborators
University of Sheffield
Lead sponsor
Christian Medical College, Vellore, India
Collaborator
KEMRI-Wellcome Trust Collaborative Research Program
Collaborator