Borrelia Species in Cutaneous Lyme Borreliosis

NCT ID: NCT00576082

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

900 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2022-12-31

Brief Summary

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The aim of this study is to identify the species of Borrelia involved in the dermatologic manifestations of Lyme borreliosis in France. Indeed, in Europe, as opposed to North America, many bacterial species are involved in Lyme borreliosis. Yet, very few is known about the prevalence and distribution of different bacteriological species that account for the disease in France. Thus, this a nation-wide study in which all French dermatologists are invited to participate. Every adult patient presenting with one of the cutaneous manifestation of Lyme borreliosis: erythema migrans, lymphocytoma or acrodermatitis chronica atrophicans can be included in the study. If the patient agrees participating, after information and written consent, a cutaneous biopsy will be performed in order to isolate Borrelia by means of culture and PCR. An estimated 400 biopsies should be performed within 2 years.

Detailed Description

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Conditions

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Lyme Borreliosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Cutaneous biopsy

Cutaneous biopsy in order to search Borrelia by means of culture and PCR in this tissue sample

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Informed adult patient who signed written consent with one the following conditions:
* erythema migrans
* borrelial lymphocytoma
* acrodermatitis chronica atrophicans

Exclusion Criteria

* pregnancy or lactation
* allergy to local anesthesia
* patient who refuses biopsy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société de Dermatologie Française

OTHER

Sponsor Role collaborator

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dan LISPKER, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

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Service de Dermatologie, Hôpital Civil

Strasbourg, , France

Site Status

Service des Maladies infectieuses et tropicales, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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3977

Identifier Type: -

Identifier Source: org_study_id

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