Lyme BorreliosisNCT00576082
Borrelia Species in Cutaneous Lyme Borreliosis
An observational study of Lyme Borreliosis, run by University Hospital, Strasbourg, France at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lyme Borreliosis
- What is being tested?
- Cutaneous biopsy
- How many people
- 900 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2008to Dec 2022
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every adult patient presenting with either erythema migrans, borrelial lymphocytoma or acrodermatitis chronica atrophicans
Who may be able to join
- Informed adult patient who signed written consent with one the following conditions:
- erythema migrans
- borrelial lymphocytoma
- acrodermatitis chronica atrophicans
Who cannot join
- pregnancy or lactation
- allergy to local anesthesia
- patient who refuses biopsy
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de Dermatologie, Hôpital Civil
Strasbourg, 67091
Service des Maladies infectieuses et tropicales, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: 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.
- Conditions
- Lyme Borreliosis
- Being tested
- Cutaneous biopsy
- Keywords
- Lyme borreliosis, Erythema migrans, Borrelial lymphocytoma, Acrodermatitis chronica atrophicans, Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii
- Medical subject headings
- Lyme Disease, Glossitis, Benign Migratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cutaneous biopsyOther
Cutaneous biopsy in order to search Borrelia by means of culture and PCR in this tissue sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startMar 2008
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme BorreliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Société de Dermatologie Française
- Responsible party
- Sponsor
- Investigators
- Dan LISPKER, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576082
- Sponsor's protocol ID
- 3977
- Status last verified
- Jun 2022
- First submitted
- 17 Dec 2007
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No