Status:
UNKNOWN
Direct Diagnosis of Disseminated Lyme Borreliosis.
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Lyme Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 prese...
Detailed Description
Lyme borreliosis is a multisystemic bacterial infection affecting the skin, the joint and the nervous system. It has been shown that the skin is an essential interface as a site of bacteria inoculatio...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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)
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 7 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04719962
Start Date
July 7 2021
End Date
July 7 2022
Last Update
May 11 2022
Active Locations (1)
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1
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091