Direct Diagnosis of Disseminated Lyme Borreliosis.

NCT04719962 | Unknown

• 1 other identifier: 7609
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

targeted proteomics; skin biopsy; biomarker

Outcome Measures

Primary Outcomes (1)

• Direct diagnosis of disseminated Lyme disease by proteomics

  1. Detection or not of targeted proteins by SRM-MS in healthy-looking skin samples of patients with disseminated Lyme borreliosis (either clinical presentation) 2. Detection or not of targeted borrelial proteins by SRM-MS in synovial fluid of patients with Lyme arthritis 3. Detection or not of targeted borrelial proteins by SRM-MS incerebrospinal fluid of patients with neuroborreliosis 4. Detection or not of targeted borrelial proteins by SRM-MS in lesional skin of patients with acrodermatitis chronica atrophicans

  6 months

Study Arms (1)

Disseminated Lyme infection

EXPERIMENTAL

Only patients presenting with disseminated Lyme borreliosis will be part of the study.

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

Interventions

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

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.

Disseminated Lyme infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject over 18 years of age
• Subject informed of the results of the previous medical examination and informed about research objectives and risks
• Subject affiliated to a social health insurance
• Subject having signed informed consent
• Subject with clinical and serological criteria that meet the criteria of French societies, published in May and June 2019 (Jaulhac et al., 2019) as well as the European criteria of ESGBOR, corresponding to a disseminated infection of Lyme borreliosis.
• Clinical Criteria:
• acute or subacute meningoradiculitis in a subject exposed to tick bites
• Uni- or bilateral peripheral facial paralysis in a subject exposed to tick bites
• Chronic radiculitis table compatible with Lyme borreliosis
• mono- or oligo arthritis of large jointsin the absence of other obvious diagnosis (inflammatory rheumatism flares, microcrystalline arthritis…)
• Skin changes suggestive of acrodermatitis chronica atrophicans
• Serological criteria: positivity for Lyme serology (two-tiered, IgG)

You may not qualify if:

• contraindication to performing a skin biopsy
• contraindication to local lidocaine anaesthesia with or without adrenaline
• contraindication to dermocorticoids (hypersensitivity)
• antibiotic treatment for borreliosis already administered
• inability to provide informed information
• Subject under safeguard of justice

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Lyme Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Benoît JAULHAC

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benoît JAULHAC

CONTACT

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

Nathalie BOULANGER

CONTACT

+33 3 69 55 14 49; nathalie.boulanger@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: July 7, 2021
• Primary Completion: July 7, 2021
• Study Completion: July 7, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Locations

FR (1)