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Borrelia Species in Cutaneous Lyme Borreliosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00576082
Recruitment Status : Recruiting
First Posted : December 18, 2007
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Société de Dermatologie Française
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date December 17, 2007
First Posted Date December 18, 2007
Last Update Posted Date April 17, 2019
Actual Study Start Date March 2008
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Borrelia Species in Cutaneous Lyme Borreliosis
Official Title DIVERSITY OF BORRELIA SPECIES INVOLVED IN CUTANEOUS MANIFESTATIONS OF LYME BORRELIOSIS IN FRANCE
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Cutaneous biopsy specimen
Sampling Method Probability Sample
Study Population Every adult patient presenting with either erythema migrans, borrelial lymphocytoma or acrodermatitis chronica atrophicans
Condition Lyme Borreliosis
Intervention Other: Cutaneous biopsy
Cutaneous biopsy in order to search Borrelia by means of culture and PCR in this tissue sample
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 21, 2018)		 900
Original Estimated Enrollment
 (submitted: December 17, 2007)		 400
Estimated Study Completion Date April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Dan LIPSKER, MD 33.3.88.11.61.79 dan.lipsker@chru-strasbourg.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00576082
Other Study ID Numbers 3977
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor University Hospital, Strasbourg, France
Collaborators Société de Dermatologie Française
Investigators
Principal Investigator: Dan LISPKER, MD Hôpitaux Universitaires de Strasbourg
PRS Account University Hospital, Strasbourg, France
Verification Date April 2019