LYME-UK: A prospective observational cohort study of early Lyme disease within the primary care setting
Lyme disease
The study will follow patients for up to 12 months without altering their standard treatment. Participants will be recruited from primary care settings when they present with suspected Lyme disease and meet the study’s inclusion criteria. They will receive standard antibiotic treatment as determined by their clinicians. Research samples—including blood and urine—will be collected solely for research purposes and will not influence clinical care. These samples will be processed separately from standard NHS tests, even if taken during the same venipuncture. Control participants, with no history or symptoms of Lyme disease, will be recruited from the Merseyside region, where Lyme disease incidence is low. They will provide a single set of samples and data at baseline, with no follow-up. After recruitment, a panel of clinical experts will assess and stratify participants based on diagnostic certainty, using both lab results (e.g., serology, PCR from skin biopsies) and clinical data. All samples will be sent to the Scottish Lyme Disease and Tick-borne Infections Reference Laboratory (SLDTRL) for processing, storage, and analysis. Some anonymized samples will be shared with the Liverpool School of Tropical Medicine for further research. Remaining samples will be stored in a proposed UK Lyme disease repository within the Grampian biorepository facility. Participants will be given detailed information and can withdraw at any time, with unused samples destroyed upon request. At non-biopsy sites, study procedures include a baseline visit with venipuncture (19.5 ml of blood), a case report form (CRF), and a rash photograph if applicable. Follow-up visits will occur at 3 and 6 months, with similar procedures. Participants will also complete online or paper-based diaries and report forms at baseline, 3, 6, and 12 months. Due to funding constraints, some follow-ups may be limited to 6 months, though efforts will be made to extend this. At biopsy-capable sites, participants ma
1. GP identified patients who are being treated on clinical suspicion of Lyme disease. 2. Patients 18 years of age or over 3. Availability and willing to attend further appointments for blood/urine samples and complete patient questionnaires. 4. Capacity to provide informed consent to participate in the study 5. Self-caring and mobile
1. Contraindication to blood sampling 2. Extreme frailty and/or comorbidity with poor life expectancy 3. Long term antibiotic use