Borrelia Species in Cutaneous Lyme Borreliosis

June 28, 2022 updated by: University Hospital, Strasbourg, France

DIVERSITY OF BORRELIA SPECIES INVOLVED IN CUTANEOUS MANIFESTATIONS OF LYME BORRELIOSIS IN FRANCE

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service de Dermatologie, Hôpital Civil
      • Strasbourg, France, 67091
        • Service des Maladies infectieuses et tropicales, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Every adult patient presenting with either erythema migrans, borrelial lymphocytoma or acrodermatitis chronica atrophicans

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Collaborators

Société de Dermatologie Française

Investigators

  • Principal Investigator: Dan LISPKER, MD, Hopitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2008

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3977

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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