Clinicaly Manifested Reinfections with Borrelia Burgdorferi Sensu Lato

NCT06835075 | Active Not Recruiting

• 1 other identifier: 0120-551/2023/3
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lyme Borreliosis

Keywords

Lyme borreliosis; Reinfection; Borrelia burgdorferi sensu lato

Outcome Measures

Primary Outcomes (3)

• The frequency of clinically detectable reinfections and identification of the circumstances under which they occur

  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: 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.

  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

  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.

  The time frame between primary EM and EM as a result of reinfection ranges from 1 month to 35 years.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with definitive Lyme borreliosis at LBOC in the period 35 years (1989 to 2023).

You may qualify if:

• Diagnosis of definitive Lyme borreliosis

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

Department of Infectious Diseases, University Medical Centre Ljubljana

Ljubljana, 1525, Slovenia

Location

MeSH Terms

Conditions

Lyme Disease; Reinfection

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Recurrence; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 19, 2025
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)