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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03798704
Recruitment Status : Not yet recruiting
First Posted : January 10, 2019
Last Update Posted : January 10, 2019
Information provided by (Responsible Party):
Maja Arnez, University Medical Centre Ljubljana

Brief Summary:
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.

Condition or disease Intervention/treatment
Lyme Disease Diagnostic Test: IFA, LIAISON

Detailed Description:

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Comparison of Immunofluorescence Assay (IFA) and Chemiluminiscence Immunoassay (LIAISON®) for Diagnosis of Early Disseminated Lyme Borreliosis in Children, Younger Than 18 Years
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lyme Disease

Intervention Details:
  • Diagnostic Test: IFA, LIAISON
    Comparison of two diagnostic serological tests - IFA and LIAISON.

Primary Outcome Measures :
  1. Sensitivity IFA vs. LIAISON [ Time Frame: 2 years ]

    LIAISON test (E/ml) is expected to be more sensitive than IFA (titer) in detection of Borrelial antibodies in children with early disseminated LB. In all patients both asseys (LIAISON and IFA) are going to be done from the same samples. The difference in the proportion of positive tests between the two assays will be statisticaly analyzed for IgM and IgG antibodies of each patient group. P values < 0,05 will be interpreted as statistically significant.

    IFA: Titres >256 in serum and >4 in CSF will be considered positive. LIAISON values in serum: the values of IgM and IgG in serum <18 in <10 E/ml will be considered as negative, 18-22 and 10-15 E/ml will be considerd as border values and >22 in >15 E/ml will be considered as positive.

    LIAISON in cerebral fluid: the values of IgM in IgG in cerebral fluid <2,5 and <4,5 E/ml will be considered as negative, values 2,5-3,5 and 4,5-5,5 E/ml will be considered as border values and >2,5 in >5,5 E/ml will be considered as positive.

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Younger then 18 years

Children younger than 18 years with early disseminated Lyme disease:

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

Additional Information:

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Responsible Party: Maja Arnez, izr. prof. dr. Maja Arnez, dr. med, University Medical Centre Ljubljana Identifier: NCT03798704     History of Changes
Other Study ID Numbers: Arnez 0120-134/2018
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maja Arnez, University Medical Centre Ljubljana:
Lyme disease
Additional relevant MeSH terms:
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Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections