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Direct Diagnosis of Disseminated Lyme Borreliosis.

NCT04719962 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-05-11

No results posted yet for this study

Summary

Lyme borreliosis is a bacterial multisystemic infection transmitted by an Ixodes tick. It affects the skin, the joint and the brain. At the early phase, the diagnosis is clinical, relying on the presence of an erythema migrans at the site of the tick bite. The diagnosis of disseminated infections, more difficult to assess, mainly relies on indirect diagnosis test, i.e. serology.

This study will evaluate a new direct diagnosis method based on proteomics, which aims to demonstrate proteins of live bacteria in the skin and the synovial or cerebrospinal fluids in a direct manner.

Conditions

  • Lyme Disease

Interventions

PROCEDURE

Targeted proteomics in skin +/- cerebrospinal or synovial fluid to diagnose disseminated Lyme disease

Following a 2-days course of local daily clobetasol propionate 0,05% cream application, a skin biopsy (3 mm punch-biopsy ) of healthy-looking skin of the upper part of the thigh will be performed in all patients,. Arthrocentesis (in patients with Lyme arthritis only) and lumbar puncture to collect cerebrospinal fluid (in patients with neuroborreliosis only) will be performed in the usual care setting as appropriated. All biological samples will be subject to Borrelia culture, PCR and SRM-MS proteomics.

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Benoît JAULHAC · Hôpitaux Universitaires de Strasbourg

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2021-07-07
Completion
2022-07-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04719962 on ClinicalTrials.gov