Transcriptomic Responses for the Identification of Pathogens

Launched by UNIVERSITY OF SHEFFIELD · May 5, 2021

Keywords

ClinConnect Summary

This clinical trial is focused on improving how we identify and diagnose enteric fever, which includes illnesses like typhoid and paratyphoid fever, in people who have fever without a clear cause. Researchers are looking at how the body's genes respond to these infections to help better understand and differentiate between various types of fever. The goal is to develop a simple test that can quickly provide results in areas where these diseases are common, helping healthcare providers manage patients more effectively.

To participate in the trial, you must be between the ages of 15 and 65, and experiencing fever or have a recent blood test confirming enteric fever. If you decide to join, you’ll need to give your consent, and after your initial visit, you’ll have a follow-up discussion by phone about two weeks later. It's important to know that certain health conditions, recent treatments, or specific situations like being hospitalized or vaccinated recently may prevent you from participating. This trial aims to gather important data, and your involvement could help improve the diagnosis and treatment of febrile illnesses in the future.

Gender

ALL

Eligibility criteria

• • 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:
• 1. 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
• • 2. 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.