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

NCT03798704 | Completed

• 1 other identifier: Arnez 0120-134/2018
• Study Type: observational
• Target: 349
• Locations: 1 country
• Sites: 1

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.

Conditions

Lyme Disease

Keywords

Lyme disease; IFA; LIAISON; children; Slovenia

Outcome Measures

Primary Outcomes (1)

• Sensitivity IFA vs. LIAISON

  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.

  2 years

Interventions

IFA, LIAISON DIAGNOSTIC_TEST

Comparison of two diagnostic serological tests - IFA and LIAISON.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University clinical center

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Lyme Disease

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: izr. prof. dr. Maja Arnez, dr. med

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: January 10, 2019
• Study Start: January 29, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

SL (1)