Borrelia Species in Cutaneous Lyme Borreliosis

Lyme Borreliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00576082
• Other study ID #: 3977
• Status: Active, not recruiting
• Start date: March 2008
• Est. completion date: December 2022

Study information

• Verified date: June 2022
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 900
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lyme Borreliosis
• Lyme Disease

Intervention

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

Locations

Country	Name	City	State
France	Service de Dermatologie, Hôpital Civil	Strasbourg
France	Service des Maladies infectieuses et tropicales, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France	Société de Dermatologie Française

Country where clinical trial is conducted

France,