Humans infected with an arbovirus Infections and Infestations
Conditions
Interventions
This observational cohort study aims to recruit 100-200 participants who are followed up for up to 6 months post arboviral infection. Participants will complete a quality-of-life questionnaire (EQ-5D-
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years old and above 2. Laboratory confirmed or clinically highly suspected arbovirus infection, defined by: a clinically highly suspected arbovirus is a compatible clinical syndrome in the opinion of the supervising clinician. For example but not exclusively, a patient presenting with a syndrome which may include: 2.1. CNS infection 2.2. Fever and rash 2.3. Fever and myalgia 2.4. Fever and arthralgia 2.5. Plus a negative malaria test 3. Recent travel from another country
Exclusion criteria
Exclusion criteria: Clinical syndrome incompatible with the positive diagnostic test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish a multi-centre study to recruit up to 200 patients with confirmed arbovirus infections, recruiting from designated sentinel sites to store reference short-term and long-term biological material from across the UK. A participant has been recruited once they have signed an informed consent form, with each participant staying within the study for a maximum of 240 days from presentation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Collect clinical follow-up data and samples from participants measured using data collected in REDCap, to support the Health Protection Research Unit (HPRU) in Emerging and Zoonotic Infections (EZIs) arbovirus diagnostic development, via percentage CRF completion, at one month and 6 months post-diagnosis 2. Collect peripheral blood mononuclear cells (PBMC) from selected cases in sites with processes in place and the capability to do so, measured using sample collection, to study the natural history of immune responses in well-characterised single virus exposure, aiming to identify optimal epitopes for inclusion in second generation vaccines at Day 0, Day 30 and Day 180 3. To study epitope specificity and how the immune response may change over time from infection to 6 months post-infection Exploratory scientific objectives 1. To describe the burden of disease and resource utilisation of imported arbovirus infections in the UK, measured using collected medical data of length and type of stay, medication prescribed, and care provided at the end of the study 2. To develop a cohort as a resource for future studies, such as diagnostic studies, or vaccine trials in people with well-defined previous exposure measured using clear documentation and categorization of the exposure history at the end of the study 3. To examine the long-term post-infectious sequelae and effects on people post Arboviral infection, measured using the EQ-5D-5L quality of life questionnaire at Day 0, 30 and 180 | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactRavi Lad
Outcome results
None listed