An observational study in Enteric Fever, Acute Febrile Illness and Typhoid, sponsored by University of Sheffield. Recruiting at 1 site in India. Open to participants aged 2 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by University of Sheffield · Observational
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.
76 studies on the registry are indexed under Typhoid Fever; 11 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 1,485 across 10 observational studies indexed under Typhoid Fever.
Browse Typhoid Fever studies →University of Sheffield is the lead sponsor of 75 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
We will recruit adults aged 15 to 65 years presenting to hospital with fever at 2 sites: 1 in Asia and 1 in Africa where enteric fever is endemic. All included febrile participants will have a (documented) tympanic/rectal temperature of ≥ 38°C or an axillary/oral temperature of ≥ 37.8°C on presentation and will report a history of fever within the last 24 hours lasting 3 to 14 days. In parallel, healthy community control participants will be recruited from each site catchment area during the course of the study with enrolment designed to result in an even representation of age groups and seasonal variation. Identified signatures of infection will be explored in a cohort of febrile children aged 2 to 14 years at each site. 600 febrile adults, 200 febrile children and 200 afebrile adult controls will be recruited at each site.
FEBRILE ADULTS- INCLUSION CRITERIA
And either:
Febrile illness without localising features (see 'exclusion criteria' and 'screening' sections) where fever is defined as:
FEBRILE ADULTS- EXCLUSION CRITERIA
For patients with febrile illness (included in (1) above): Any history or clinical suspicion of:
CONTROLS- INCLUSION CRITERIA
CONTROLS- EXCLUSION CRITERIA
Current treatment for or prior history, or clinical suspicion of:
EXPLORATORY AIMS- PAEDIATRIC CRITERIA; INCLUSION CRITERIA
EXPLORATORY AIMS- PAEDIATRIC CRITERIA; EXCLUSION CRITERIA
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1200 adult participants (15 to 65 years old) with a febrile illness without localising features and reported duration of 3-14 days.
Diagnostic Test: 5-gene transcription signature
400 afebrile, healthy adult participants (15 to 65 years old).
Diagnostic Test: 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.
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.
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.
Evaluate the performance of a host gene transcription signature for detecting enteric fever in adults presenting with acute undifferentiated fever (AUFI)
Time frame: 2.5 years
Number of participants with diagnosis confirmed by laboratory testing.
Determine the frequency of other common causes of AUFI at each site.
Time frame: 2.5 years
Number of participants presenting with mild, moderate or severe illness by clinical diagnosis according to validated prognostic scores such as sepsis scoring systems.
Assess the relationship between markers of clinical illness severity, likely infection cause and level of molecular perturbation.
Time frame: 2.5 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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