LYME-UK – A study of early Lyme disease within GPs in the UK
| ISRCTN | ISRCTN16352397 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16352397 |
| IRAS number | 300238 |
| Secondary identifying numbers | CPMS 60167 |
- Submission date
- 11/08/2025
- Registration date
- 23/10/2025
- Last edited
- 23/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Lyme disease is a bacterial infection that occurs in humans through the bite of an infected tick. This is known as a vector-borne disease and Lyme disease is the most common vector-borne disease in the United Kingdom, Europe, and North America. Despite increasing public concern and media attention, there is limited knowledge about how many infections occur, how we accurately diagnose these, and what the long-term outcomes of infections are within the UK. The overall aim is to understand the disease and treatment outcomes over a year, in patients who attend their GP with suspected Lyme disease and are treated with antibiotics.
Who can participate?
Adults aged 18 and over.
What does the study involve?
The study requires 3 clinical visits, to collect blood and urine sample at 3 timepoints, and an optional skin biopsy at baseline. We will also ask symptoms questionnaires over 12 months at 10 timepoints.
What are the possible benefits and risks of participating?
This study will provide data from the tick bite, symptoms, treatment outcomes and serology profile for patients with a diagnosed early infection, within the UK. Participating in the study will enable participants to contribute towards baseline and follow-up data, to help improve understanding of diagnosis and treatment outcomes in patients. Clinical samples will be used in future research to understand Lyme disease infection and to develop improved and new ways to diagnose Lyme disease earlier and more accurately. There is no direct benefit for participants – travel will be reimbursed up to £20 per visit. There is some risk associated with providing a blood sample, with potential discomfort and a small risk of bruising. For participants that provide consent for a skin punch biopsy, there is an additional small risk of infection and discomfort from the procedure. You may also be asked to attend for an extra clinic visit to check healing and removal of a suture if this is used in the procedure.
Where is the study run from?
The study is sponsored by The University of Liverpool. Study and data management is provided by the Global Health Trials Unit, at Liverpool School of Tropical Medicine (UK)
When is the study starting and how long is it expected to run for?
August 2022 to March 2030
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Professor Neil French, N.French@liverpool.ac.uk
Study coordinator – Ravi Lad, ravi.lad@lstmed.ac.uk
Contact information
Scientific, Principal investigator
University of Liverpool
Liverpool
L69 3BX
United Kingdom
 ORCID ID |
0000-0003-4814-8293 |
|---|---|
| Phone | +44 (0)151 795 9630 |
| N.French@liverpool.ac.uk |
Public
Liverpool School of Tropical Medicine
Liverpool
L69 3BX
United Kingdom
| ORCID ID |
0009-0007-1775-350X |
|---|---|
| Phone | +44 151 705 3364 |
| ravi.lad@lstmed.ac.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | LYME-UK: A prospective observational cohort study of early Lyme disease within the primary care setting |
| Study acronym | LYME-UK |
| Study objectives | The study hopes to understand the disease and treatment outcomes over a year, in patients who attend their GP with suspected Lyme disease and are treated with antibiotics as described in the current NICE guidance. |
| Ethics approval(s) |
Approved 23/08/2022, Wales Research Ethics Committee 5 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 2922 941106; Wales.REC5@Wales.nhs.uk), ref: 22/WA/0228 |
| Health condition(s) or problem(s) studied | Lyme disease |
| Intervention | 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 may undergo a minor skin biopsy (2–3 mm) from the rash’s edge, following local anaesthetic. This procedure is limited to those who have taken no more than two days of antibiotics to ensure accurate PCR results. All other procedures mirror those at non-biopsy sites. Control participants will be age and gender matched, recruited from the North West of England, and ideally already scheduled for routine venipuncture. They will attend a single appointment for consent, sample collection, and a brief CRF, with no further follow-up. Participants will be reimbursed for travel costs. A potential sub-study involving patient-reported outcomes from the UKHSA tick surveillance scheme is mentioned but not yet approved. If viable, it will include participants who report tick bites and Lyme disease, contributing data without clinic visits or sampling. Ethics approval will be sought if this sub-study is pursued. |
| Intervention type | Other |
| Primary outcome measure | Measured using patient records unless noted: 1. Antibiotic treatment duration and patient compliance over 12 months 2. EM rash resolution with standard treatment over 12 months 3. Longitudinal symptom and severity reporting (Patient Reported Outcome) over 12 months 4. Serology evolution and profile at baseline, 3 and 6 months 5. Microbiological status (skin biopsy subgroup) at diagnosis 6. Patient reported outcomes post-baseline up to 12 months |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 23/08/2022 |
| Completion date | 31/03/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 36 |
| Key inclusion criteria | 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 |
| Key exclusion criteria | 1. Contraindication to blood sampling 2. Extreme frailty and/or comorbidity with poor life expectancy 3. Long term antibiotic use |
| Date of first enrolment | 26/07/2023 |
| Date of final enrolment | 31/03/2029 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
17 Old Edinburgh Road
Inverness
IV2 3HG
United Kingdom
Sponsor information
University/education
PO Box 147
Liverpool
L69 3BX
United Kingdom
| Phone | +44 (0)151 794 8739 |
|---|---|
| sponsor@liverpool.ac.uk | |
| Website | http://www.liv.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Ravi Lad, ravi.lad@lstmed.ac.uk, anonymous data, after the study close for 15 years, via application and approval from the LYME-UK study team. Any types of analyses. If data are required to be shared, these requests will be documented and saved in the study file, for audit purposes, and all requests will be reviewed and approved by the CI. Data will be transferred through a secure and encrypted portal, to ensure that the file(s) has not been corrupted, maintaining transparency and integrity. All data transfers will abide by the GDPR 2016/679. |
Editorial Notes
11/08/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
