Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-03-05 @ 7:04 PM
Study NCT ID:
NCT03798704
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2018-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of IFA and LIAISON® for Diagnosis of Early Disseminated Lyme Borreliosis in Children, Younger Than 18 Years
Sponsor:
University Medical Centre Ljubljana
Organization:
Study Overview
Official Title:
Comparison of Immunofluorescence Assay (IFA) and Chemiluminiscence Immunoassay (LIAISON®) for Diagnosis of Early Disseminated Lyme Borreliosis in Children, Younger Than 18 Years
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: