Actively Recruiting
Transcriptomic Responses for the Identification of Pathogens
Led by University of Sheffield · Updated on 2025-03-03
2000
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
Sponsors
U
University of Sheffield
Lead Sponsor
C
Christian Medical College, Vellore, India
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcriptomic Responses for the Identification of Pathogens
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 15 to 65 years for adults, or 2 to less than 15 years for pediatric exploratory aims
- Willingness and ability to provide informed consent (and assent for children aged 8-14 years)
- Febrile illness without localizing features with fever defined as documented temperature 38�B0C (tympanic/rectal) or 37.8�B0C (axillary/oral) or reported fever in last 24 hours
- Reported duration of fever between 3 and 14 days, or recently confirmed blood culture indicating enteric fever within 5 days
- Recent exposure to antimicrobials allowed
- Controls must be afebrile with temperature 38�B0C (tympanic/rectal) or 37.8�B0C (axillary/oral)
- Controls must live outside the normal/local catchment area for each hospital site
You will not qualify if you...
- Unable to provide informed consent with no willing next of kin or guardian
- History or suspicion of rheumatological or connective tissue disorders
- Autoimmune conditions
- Malignancy
- Active treatment with immunomodulating medications or for tuberculosis or chronic infections
- Pregnancy (breastfeeding mothers allowed)
- Hospitalization for more than 48 hours in the last 4 weeks (for febrile adults) or hospitalization within 4 weeks of recruitment (for controls)
- Vaccination within 4 weeks prior to admission or recruitment
- Localizing signs or symptoms sufficient to diagnose cause of acute febrile illness
- For controls: antimicrobial use within 4 weeks of recruitment
- Participant reports feeling more unwell than usual on day of enrolment (controls)
- For pediatric participants: unwillingness of parent/guardian or patient aged 8 to 14 years to provide consent/assent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Christian Medical Centre
Vellore, India
Actively Recruiting
Research Team
F
Farah Shahi
CONTACT
T
Thomas Darton
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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