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

Lyme Borreliosis Clinical Trial

— CXCL13-LYME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625100
• Other study ID #: 7885
• Status: Recruiting
• Start date: July 13, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: University Hospital, Strasbourg, France
• Contact: Benoit JAULHAC, MD, PhD
• Phone: 33 3 69 55 14 52
• Email: benoit.jaulhac[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 141
• Est. completion date: December 31, 2023
• Est. primary completion date: December 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lyme Borreliosis
• Lyme Disease
• Lyme Neuroborreliosis

Locations

Country	Name	City	State
France	Service Laboratoire de Bactériologie - Plateau Technique de Microbiologie - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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