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UnknownNCT05625100

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

Status
Unknown
Phase
Study type
Observational
Enrollment
141 (estimated)
Sponsor
University Hospital, Strasbourg, France · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

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

Timeline

Start date
2020-07-13
Primary completion
2023-12-01
Completion
2023-12-31
First posted
2022-11-22
Last updated
2023-10-31

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05625100. Inclusion in this directory is not an endorsement.

Place of Intrathecal CXCL-13 in the Diagnosis of Lyme Neuroborreliosis (NCT05625100) · Clinical Trials Directory