Comparison of IFA and LIAISON® for Diagnosis of Early Disseminated Lyme Borreliosis in Children, Younger Than 18 Years

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

349 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-29

Study Completion Date

2020-12-31

Brief Summary

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The aim of this study is to compare two different serological tests, IFA and LIAISON, for detection of Borrelia burgdorferi sensu lato IgM and IgG antibiodies in children with early disseminated Lyme borreliosis.

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Detailed Description

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Slovenia is highly endemic region for Lyme borreliosis (LB). LB is a tick - borne multisystem infectious disease caused by Borrelia burgdorferi sensu lato.

Solitary erythema migrans (SEM) is a typical clinical manifestation of early localized LB and microbiological confirmation of borrelial infection is not required for diagnosis.

Clinical manifestations of early disseminated LB (multiple erythema migrans (MEM), peripheral facial palsy and meningitis) are not characteristic enough to enable a reliable diagnosis, indicating the need for laboratory demonstration of borrelial infection which is mainly accomplished with serological tests.

For detection of borrelial antibodies several methods are used, such as immunofluorescent assay (IFA), enzyme immunoassay (EIA) and immunoblots. Serological tests are not standardized and have limited sensitivity and specificity.

The aim of this study is to specify and compare the sensitivity of IFA and LIAISON serological tests in early disseminated LB in children in Slovenia.

The secondary aim is to determine the influence of early antibiotic treatment of early disseminated LB on serological results in children with LB in Slovenia and to compare the serological results in children who are treated with antibiotics immediately and those who are treated later in the course of the study.

Conditions

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Lyme Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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IFA, LIAISON

Comparison of two diagnostic serological tests - IFA and LIAISON.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Children younger than 18 years with early disseminated Lyme disease:

* multiple erythema migrans
* peripheral facial nerve palsy
* lymphocytic meningitis

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No