Does Borrelia Burgdorferi Increases the Risk of Auto-immune Disease ? (DOBI)
Lyme borreliosis (LB) is an infectious disease that may be followed by a post-infectious syndrome known as PTLDS: Post-Treatment Lyme Disease Syndrome.
Its pathophysiological mechanism is currently not fully understood, but several hypotheses have been proposed, including the induction of autoimmune phenomena following infection with Borrelia burgdorferi, either due to the bacterium itself or as a consequence of prolonged antibiotic therapy.
The frequency of occurrence of an autoimmune disease (AID) following Lyme borreliosis is currently unknown. Describing its incidence is a necessary first step.
The goal of this observational study is to describe the incidence of autoimmune disease occurring within six months after treated Lyme borreliosis.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Nancy, Frankrig
- CHRU Nancy
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
All patients attending a Regional Reference Center for Tick-Borne Diseases included in the TACTIQUES database and meeting the inclusion criteria.
Beskrivelse
Inclusion Criteria:
- Adult individual who has received full information about the organization of the research and has not objected to the use of their data.
- Individual included in the TAC TIQUES database.
- Individual diagnosed with Lyme borreliosis (LB) at the time of their visit to the center or previously, regardless of the stage of LB (localized, early disseminated, or late disseminated).
- Individual with at least one follow-up consultation six months or more after the LB diagnosis (including cases of erythema migrans treated before the consultation at the Regional Reference Center for Tick-Borne Diseases).
Exclusion Criteria:
- Individual free of Lyme borreliosis (LB).
- Individual with a diagnosis of systemic or organ-specific autoimmune disease (AID) prior to the LB diagnosis.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: RETROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
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TACTIQUES
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Occurrence of an autoimmune disease during follow-up
Tidsramme: up to six months
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Occurrence of any autoimmune disease up to six months after Lyme borreliosis had been treated |
up to six months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Occurrence of an autoimmune disease during follow-up
Tidsramme: through study completion, up to 4 years
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through study completion, up to 4 years
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Nature of the auto-immune disease
Tidsramme: through study completion, up to 4 years
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through study completion, up to 4 years
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To assess the time to onset of an auto-immune disease after Lyme borreliosis
Tidsramme: through study completion, up to 4 years
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through study completion, up to 4 years
|
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To identify factors associated with the occurrence of an autoimmune disease within six months following LB.
Tidsramme: up to six months after Lyme borreliosis had been treated, through study completion, up to 4 years
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up to six months after Lyme borreliosis had been treated, through study completion, up to 4 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Elisabeth BAUX, Department of Infectious Diseases, University Hospital of Nancy
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2025PI131-691
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Data collection is carried out at each center using a data collection form completed on an e-CRF.
The forms are stored for five years after the publication of the research results on a secure server specialized in health data (Epiconcept).
Data transfer between CHG de Villeneuve Saint Georges and CHRU de Nancy is performed via a virtual ticket allowing data retrieval, accessible for 24 hours.
Finally, data analysis is conducted in an Excel file on the server of the CHRU of Nancy
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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