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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinicaly Manifested Reinfections with Borrelia Burgdorferi Sensu Lato
- ClinicalTrials.gov ID
- NCT06835075
- Acronym / sponsor ID
- 0120-551/2023/3
- Conditions
- Lyme Borreliosis
- Keywords
- Lyme borreliosis, Reinfection, Borrelia burgdorferi sensu lato
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15,000 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with definitive Lyme borreliosis at LBOC in the period 35 years (1989 to 2023).
Key inclusion criteria (1 listed)
- Diagnosis of definitive Lyme borreliosis
Key exclusion criteria (1 listed)
- /
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The frequency of clinically detectable reinfections and identification of the circumstances under which they occur
Time frame: 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
Time frame: The time frame between primary EM and EM as a result of reinfection ranges from 1 month to 35 years.
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: i) 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.
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
Time frame: The time frame between primary EM and EM as a result of reinfection ranges from 1 month to 35 years.
1. We will compare the proportion of positive cultures in patients with a primary cutaneous lesion of EM versus patients with EM due to reinfection. 2. 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Derived from this study: PubMed 41703273Strle 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.
- Individual participant dataSharing planned: No. Personal, highly confidential data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Borreliosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of clinically detectable reinfections and identification of the circumstances under which they occur (time frame: At diagnosis). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06835075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.