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Borrelia Species in Cutaneous Lyme Borreliosis

This study is currently recruiting participants.
Verified September 2012 by University Hospital, Strasbourg, France
Sponsor:
Collaborator:
Société de Dermatologie Française
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00576082
First received: December 17, 2007
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Lyme Borreliosis
 Other: Cutaneous biopsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: DIVERSITY OF BORRELIA SPECIES INVOLVED IN CUTANEOUS MANIFESTATIONS OF LYME BORRELIOSIS IN FRANCE

Resource links provided by NLM:

MedlinePlus related topics: Lyme Disease
U.S. FDA Resources

Further study details as provided by University Hospital, Strasbourg, France:

Biospecimen Retention:   Samples With DNA

Cutaneous biopsy specimen


Estimated Enrollment: 600
Study Start Date: March 2008
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Cutaneous biopsy
    Cutaneous biopsy in order to search Borrelia by means of culture and PCR in this tissue sample
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576082

Contacts
Contact: Dan LIPSKER, MD 33.3.88.11.61.79 dan.lipsker@chru-strasbourg.fr

Locations
France
Service de Dermatologie, Hôpital Civil Recruiting
Strasbourg, France, 67091
Contact: Dan LIPSKER, MD     33.3.88.11.61.79     dan.lipsker@chru-strasbourg.fr    
Contact: Benoît JAULHAC, MD     33.3.90.24.37.80     benoit.jaulhac@medecine.u-strasbg.fr    
Principal Investigator: Dan LIPSKER, MD            
Sub-Investigator: Benoît JAULHAC, MD            
Sub-Investigator: Bernard CRIBIER, MD            
Sub-Investigator: Carine KIEFFER, MD            
Sub-Investigator: Eric FROUIN, MD            
Sub-Investigator: Pauline LEMORDANT, MD            
Sub-Investigator: Cécile PERRIGOUARD, MD            
Sub-Investigator: Jean-Nicolas SCRIVENER, MD            
Sub-Investigator: Virginie LUTZ, MD            
Service des Maladies infectieuses et tropicales, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67091
Contact: Yves HANSMANN, MD     33.3.69.55.09.78     yves.hansmann@chru-strasbourg.fr    
Sub-Investigator: Yves HANSMANN, MD            
Sub-Investigator: Guillaume CAMUSET, MD            
Sponsors and Collaborators
University Hospital, Strasbourg, France
Société de Dermatologie Française
Investigators
Principal Investigator: Dan LISPKER, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00576082     History of Changes
Other Study ID Numbers: 3977
Study First Received: December 17, 2007
Last Updated: September 24, 2012
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Lyme borreliosis
Erythema migrans
Borrelial lymphocytoma
Acrodermatitis chronica atrophicans
 Borrelia burgdorferi
Borrelia afzelii
Borrelia garinii

Additional relevant MeSH terms:
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
 Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections

ClinicalTrials.gov processed this record on May 16, 2013