Place of Intrathecal CXCL-13 in the Diagnosis of Lyme Neuroborreliosis

NCT05625100 | Unknown

• 1 other identifier: 7885
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

Neuroborreliosis (NBL) is diagnosed in 10-15% of patients with Lyme borreliosis. In Europe in adults, the main clinical manifestation is called "Bannwarth syndrome". This includes painful meningoradiculitis, sometimes accompanied by cranial nerve neuritis. Current European guidelines issued by the European Federation of Neurological Societies (EFNS) recommend the following triad for the diagnosis of "definite NBL": (i) Neurological symptoms suggestive of NBL without any other obvious cause; (ii) CSF pleocytosis; (iii) Intrathecal production of specific anti-Borreliella antibodies. CXCL13, C-X-C chemokine motif ligand 13, is a chemokine implicated in B cell chemotaxis. Extensive literature exists on the analysis of CXCL13i as a diagnostic marker for acute NBL. A recent meta-analysis from 2018, published by Rupprecht et al finds an overall sensitivity and specificity of 89% and 96% respectively, indicating satisfactory diagnostic value. In this study, the investigators wish to assess the place of this new marker in the diagnosis of neuroborreliosis before proposing it as a test carried out by the Borrelia CNR.

Conditions

Lyme Borreliosis

Keywords

Lyme borreliosis; Lyme neuroborreliosis; Bannwarth syndrome; Intrathecal CXCL-13

Outcome Measures

Primary Outcomes (1)

• Positivity of the marker (CXCL13-intrathecal) for known cases of NBL and negativity of this one for known non-NBL cases

  Files analysed retrospectively from January 01, 2013 to December 31, 2018 will be examined

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Major subject (≥18 years old) subject having consulted at the HUS between 01/01/2013 and 31/12/2018

You may qualify if:

• Major subject (≥18 years old)
• Subject having consulted at the HUS between 01/01/2013 and 31/12/2018
• Subject not having, after being informed, expressed their opposition to the reuse of their data for the purposes of this research

You may not qualify if:

• Subject who expressed their opposition to participating in the study
• Subject under guardianship or curatorship
• Subject under safeguard of justice

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service Laboratoire de Bactériologie - Plateau Technique de Microbiologie - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Lyme Disease; Lyme Neuroborreliosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Benoit JAULHAC, MD, PhD

CONTACT

33 3 69 55 14 52; benoit.jaulhac@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: July 13, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 31, 2023
• Last Updated: October 31, 2023

Record last verified: 2022-11

Locations

FR (1)