Lyme BorreliosisNCT06835075
Clinicaly Manifested Reinfections with Borrelia Burgdorferi Sensu Lato
An observational study of Lyme Borreliosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Data on reinfections with B. burgdorferi sensu lato in humans are scarce; they are limited to case reports and a few small groups of patients, mostly from the USA and less frequently from Europe. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lyme Borreliosis
- How many people
- 15,000 participants
- Where
- 1 siteSlovenia
- Study dates
- 31 Dec 2024to 31 Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with definitive Lyme borreliosis at LBOC in the period 35 years (1989 to 2023).
Who may be able to join
- Diagnosis of definitive Lyme borreliosis
Who cannot join
- /
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
Department of Infectious Diseases, University Medical Centre Ljubljana
Ljubljana, 1525
About this study
Data on reinfections with B. burgdorferi sensu lato in humans are scarce; they are limited to case reports and a few small groups of patients, mostly from the USA and less frequently from Europe. In these reports, the clinical manifestation of reinfection was usually erythema migrans and was most often documented after successful treatment of a previous infection (almost always erythema migrans). The clinical manifestations of Lyme disease in reinfection appear to be similar to those of primary infection, but there are no studies on possible differences in serological or immunological responses.
The current study has 3 primary objectives:
- To determine the frequency of clinically detectable reinfections and to identify the circumstances under which they occur;
- To determine possible differences between primary and reinfection in clinical presentation, disease course and outcome, and specific serum antibody response;
- To determine the aetiology of clinically detectable reinfections by comparing Borrelia isolates recovered from the skin of the same patient at primary and reinfection.
Read the detailed description
The current study will encompass all patients aged ≥18 years who were treated at the Department of Infectious Diseases, UMC Ljubljana for proven, clinically well-defined Lyme borreliosis in the period 1989 - 2023. Organised data collection in patients with Lyme borreliosis started in 1986 when we established an Outpatient Lyme borreliosis Clinic and introduced uniform approaches to diagnosis, treatment and follow-up of the disease course, thus obtaining a database of high quality clinical and laboratory data in a large number of patients.
The aims:
- To determine the frequency of clinically detectable reinfections and to identify the circumstances under which they occur (in a cohort of ~15000 European patients with erythema migrans and ~1500 patients with early extradermal or late Lyme disease).
- To determine possible differences between primary and reinfection in clinical presentation, disease course and outcome, and specific serum antibody response (by comparing clinical findings and serological test results in ~1500 patients who were diagnosed with erythema migrans more than 1 time).
- To determine the aetiology of clinically detectable reinfections by comparing Borrelia isolates recovered from the skin of the same patient at primary and reinfection (~100 patients and 200 isolates, respectively).
- Conditions
- Lyme Borreliosis
- Keywords
- Lyme borreliosis, Reinfection, Borrelia burgdorferi sensu lato
- Medical subject headings
- Lyme Disease, Reinfection
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of clinically detectable reinfections and identification of the circumstances under which they occur
Measured: At diagnosis
Differences between primary erythema migrans and erythema migrans as a result of reinfection according to clinical findings, the presence of borrelial antibodies, and Borrelia skin culture results
The objectives of the current study were to assess and compare findings in patients with primary erythema migrans (EM) skin lesion versus those with EM due to reinfection, including:
- clinical findings: age (years), sex, tick bite at the site of EM, duration of EM till diagnosis (days), largest diameter of EM at diagnosis (cm), ring-like EM, number of EM, local symptoms (present or absent), systemic symptoms, underlying chronic illness, abnormalities on physical examination; ii) Borrelia antibody responses (IgM ang IgG determined with chemi-luminescence immunoassay, LIAISON, Diasorin, Saluggia, Italy); iii) Borrelia skin culture positivity rate.
Measured: The time frame between primary EM and EM as a result of reinfection ranges from 1 month to 35 years.
Comparison of the aetiology of clinically detectable reinfections by comparing Borrelia isolates recovered from the skin of the same patient at primary infection and reinfection
- We will compare the proportion of positive cultures in patients with a primary cutaneous lesion of EM versus patients with EM due to reinfection.
- In the subgroup of patients in whom Borrelia were isolated from skin of primary as well as from EM as a result of reinfection, we will compare Borrelia pairs according to species (determined by PCR) and according to sequencing findings.
Measured: The time frame between primary EM and EM as a result of reinfection ranges from 1 month to 35 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start31 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lyme BorreliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petra Bogovič, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835075
- Sponsor's protocol ID
- 0120-551/2023/3
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal, highly confidential data
Publications
Strle F, Ogrinc K, Maraspin V, Lotric-Furlan S, Rojko T, Ruzic-Sabljic E, Kastrin A, Strle K, Wormser GP, Bogovic P. Clinical data on symptomatic cutaneous reinfections due to Borrelia burgdorferi sensu lato in Slovenia. Infection. 2026 Jun;54(3):1347-1358. doi: 10.1007/s15010-026-02751-9. Epub 2026 Feb 17.
PubMed 41703273