Borrelia Species in Cutaneous Lyme Borreliosis

NCT00576082 | Unknown

• 1 other identifier: 3977
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Lyme Borreliosis

Keywords

Lyme borreliosis; Erythema migrans; Borrelial lymphocytoma; Acrodermatitis chronica atrophicans; Borrelia burgdorferi; Borrelia afzelii; Borrelia garinii

Interventions

Cutaneous biopsy OTHER

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

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• pregnancy or lactation
• allergy to local anesthesia
• patient who refuses biopsy

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead
• Société de Dermatologie Française: collaborator

Study Sites (2)

Service de Dermatologie, Hôpital Civil

Strasbourg, 67091, France

Location

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

Strasbourg, 67091, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cutaneous biopsy specimen

MeSH Terms

Conditions

Lyme Disease; Glossitis, Benign Migratory

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases; Glossitis; Tongue Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Dan LISPKER, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 18, 2007
• Study Start: March 1, 2008
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Locations

FR (2)