Status:
RECRUITING
Transcriptomic Responses for the Identification of Pathogens
Lead Sponsor:
University of Sheffield
Collaborating Sponsors:
Christian Medical College, Vellore, India
KEMRI-Wellcome Trust Collaborative Research Program
Conditions:
Enteric Fever
Acute Febrile Illness
Eligibility:
All Genders
2-65 years
Brief Summary
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 prev...
Eligibility Criteria
Inclusion
- FEBRILE ADULTS- INCLUSION CRITERIA
- 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.
- FEBRILE ADULTS- EXCLUSION CRITERIA
- The participant may not enter the study if ANY of the following apply:
- Unable to provide informed consent and no next of kin is willing and able to provide informed consent.
- For patients with febrile illness (included in (1) above): Any history or clinical suspicion of:
- Rheumatological or connective tissue disorder (e.g. Rheumatoid arthritis)
- Autoimmune condition (e.g. Autoimmune Hepatitis)
- Malignancy
- Active treatment with immunomodulating medications, or for tuberculosis (pulmonary or extrapulmonary) or any other chronic infection.
- Pregnancy (breast feeding mothers will NOT be excluded)
- No hospitalisation for more than 48 hours in the last 4 weeks
- Vaccination within 4 weeks prior to current admission
- Localising signs or symptoms of infection sufficient to diagnose the likely cause of acute febrile illness and thus prevent it from being 'undifferentiated.'
- CONTROLS- INCLUSION CRITERIA
- 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).
- CONTROLS- EXCLUSION CRITERIA
- The participant may not enter the study if ANY of the following apply:
- Unable to provide informed consent and no next of kin (or parent/guardian in the case of a minor) is willing and able to provide informed consent.
- Current treatment for or prior history, or clinical suspicion of:
- Rheumatological or connective tissue disorder
- Autoimmune condition
- Malignancy
- Active treatment for tuberculosis (pulmonary or extrapulmonary) or clinical suspicion of active tuberculosis. Previous completed treatment is not a reason for exclusion.
- Active treatment with immunomodulating medications or any other chronic infection.
- Pregnant (breast feeding mothers will NOT be excluded)
- Hospitalisation within 4 weeks of recruitment
- Vaccination within 4 weeks prior to recruitment
- Antimicrobial use within 4 weeks of recruitment
- Participant reports feeling more unwell than usual on the day of enrolment.
- EXPLORATORY AIMS- PAEDIATRIC CRITERIA; INCLUSION CRITERIA
- Age greater than or equal to 2 years and less than 15 years
- As above for adult participants.
- EXPLORATORY AIMS- PAEDIATRIC CRITERIA; EXCLUSION CRITERIA
- Parent/guardian is unwilling, and/or patient aged 8 to 14 years is unwilling to assent to provide informed consent.
- As above for adult participants.
Exclusion
Key Trial Info
Start Date :
May 2 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04878549
Start Date
May 2 2022
End Date
June 1 2025
Last Update
March 3 2025
Active Locations (1)
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1
Christian Medical Centre
Vellore, India