A Multisite Evaluation of Functional Genomic Signatures for the Improved Diagnosis of Acute Undifferentiated Febrile Infections
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.
• Age greater than or equal to 15 years and less than or equal to 65 years
• 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
• And either:
‣ Febrile illness without localising features (see 'exclusion criteria' and 'screening' sections) where fever is defined as:
• 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.
• Participant is willing and they are (and in 15-18 year olds, a guardian is) able to give informed consent for participation in the study
• Age greater than or equal to 15 years and less than or equal to 65 years
• They live outside of the normal/local catchment area for each hospital site
• Afebrile (as defined by no reported fever and temperature ≤ 38°C or an axillary/oral temperature of ≤ 37.8°C).
• Age greater than or equal to 2 years and less than 15 years
• As above for adult participants.