Place of Intrathecal CXCL-13 in the Diagnosis of Lyme Neuroborreliosis (CXCL13-LYME)

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.

Study Overview

• Status: Recruiting
• Conditions: Lyme Borreliosis

• Study Type: Observational
• Enrollment (Estimated): 141

Contacts and Locations

• Study Contact: Name: Benoit JAULHAC, MD, PhD; Phone Number: 33 3 69 55 14 52; Email: benoit.jaulhac@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service Laboratoire de Bactériologie - Plateau Technique de Microbiologie - CHU de Strasbourg - France
    • Contact: Benoit JAULHAC, MD, PhD; Phone Number: 33 3 69 55 14 52; Email: benoit.jaulhac@chru-strasbourg.fr
    • Principal Investigator: Benoit JAULHAC, MD, PhD
    • Principal Investigator: Antoine GRILLON, MD
    • Sub-Investigator: Laure Dolfus, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

Inclusion criteria:

• 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

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2020
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Lyme borreliosis; Lyme neuroborreliosis; Bannwarth syndrome; Intrathecal CXCL-13
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Central Nervous System Bacterial Infections; Tick-Borne Diseases; Spirochaetales Infections; Lyme Disease; Borrelia Infections; Lyme Neuroborreliosis
• Other Study ID Numbers: 7885

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No