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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienorte
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Nancy, Frankreich
- CHRU Nancy
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
All patients attending a Regional Reference Center for Tick-Borne Diseases included in the TACTIQUES database and meeting the inclusion criteria.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: RETROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
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TACTIQUES
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Occurrence of an autoimmune disease during follow-up
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Occurrence of an autoimmune disease during follow-up
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Elisabeth BAUX, Department of Infectious Diseases, University Hospital of Nancy
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 2025PI131-691
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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