LYME-UK
Research type
Research Study
Full title
LYME-UK: A prospective observational cohort study of early Lyme disease within the primary care setting
IRAS ID
300238
Contact name
Lucy Delaney
Contact email
Sponsor organisation
University of Liverpool
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
Lyme disease is the most common vector-borne disease in the UK, Europe and North America, transmitted by a tick bite (Ixodes ricinus in the UK/Europe). Despite increasing public concern and media attention, there is limited knowledge about how many infections actually occur, how we accurately diagnose these, and what the long-term outcomes of infections are within the UK. The annual incidence of lab confirmed disease in England and Scotland includes a subset of patients, who are tested in cases of inconclusive clinical diagnosis.
In approximately 60% of early Lyme disease infections, a characteristic “bulls eye” rash (erythema migrans or EM) is evident. The EM rash alone is considered a clinical diagnosis and the patient should be treated with antibiotics, with no further testing or reporting required. Patients may present with early infection without a visible EM rash, often with vague flu-like symptoms and can be difficult to diagnose (up to 50% of patients do not recall a tick bite). Serology testing is often not useful to support diagnosis in such cases, as it depends on detecting the antibody response of the patient to the infection, which can take around 6 weeks to show a positive response. Early diagnosis and treatment of the disease is important as disseminated forms of the disease and late Lyme disease can include complications involving the nervous system, heart, skin and joints.
Improving diagnostics that can support clinical diagnosis at an early stage of infection and can identify active infection, is an important research priority. This study design provides an excellent platform to collect and characterise patient disease course and associated clinical samples, with participant consent for future use. We aim to characterise patient outcomes in early Lyme disease over a 6 to 12-month follow-up following diagnosis and standard treatment.
REC name
Wales REC 5
REC reference
22/WA/0228
Date of REC Opinion
19 Aug 2022
REC opinion
Favourable Opinion