Clinical trial Recruiting at 1 site Observational Ages 1 Year and up

Disseminated Lyme and Borrelia miyamotoi infections after anti‑CD20 treatment in France

Official title: A Multicenter Real-life Study of Disseminated Borreliosis Cases Occurring in Patients Receiving Anti-CD20 Treatment in France

Run by University Hospital, Strasbourg, France · NCT07343089 · Data updated 2026-11-12

This project looks at clinical, laboratory, imaging, and medication information from people in France who developed widespread Borrelia infections after anti‑CD20 therapy.

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Quick facts

Study typeObservational
Ages1 Year and up
SexAll
Enrollment100 (estimated)
SponsorUniversity Hospital, Strasbourg, France
Academic / other
Locations1 site (Strasbourg)
StatusRecruiting
StartedAugust 29, 2025
Main results expectedAugust 2026
Study endsAugust 29, 2026
Registry record updatedJanuary 15, 2026
Trial IDNCT07343089 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children or adults in France with molecularly confirmed disseminated Borrelia burgdorferi sl. or Borrelia miyamotoi diagnosed within 24 months after receiving an anti‑CD20 monoclonal antibody between Jan 1, 2010 and Jul 30, 2025.

Probably not a fit

Patients without molecular confirmation of Borrelia infection, those whose infection occurred more than 24 months after anti‑CD20 therapy, or those who refuse participation are unlikely to benefit from inclusion.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, real‑life observational effort led by CHU Strasbourg compiles clinical, biological, radiological, and pharmacological data on cases of disseminated Borrelia burgdorferi sensu lato or Borrelia miyamotoi occurring after anti‑CD20 monoclonal antibody therapy. Eligible cases require molecular confirmation of disseminated borreliosis occurring within 24 months of anti‑CD20 treatment given between January 1, 2010 and July 30, 2025. Data will be extracted from hospital records and laboratory results and centrally analyzed to describe presentations, diagnostic pathways, treatments, and outcomes. No experimental treatments are administered as part of the project; it is purely observational and descriptive.

Why it matters

Potential benefit: If successful, this work could help clinicians recognize, diagnose, and manage disseminated Borrelia infections in patients treated with anti‑CD20 antibodies more effectively.

How similar studies have gone: Case reports and small case series have described Borrelia infections after anti‑CD20 therapy, but comprehensive multicenter descriptive data are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Minor or adult subject
* Having presented disseminated borreliosis confirmed by molecular biology (Borrelia burgdorferi sl. or Borrelia miyamotoi) within 24 months of receiving treatment with an anti-CD20 monoclonal antibody between January 1, 2010, and July 30, 2025.

Exclusion Criteria:

\- Refusal to participate in the study

Where it's running

  • Laboratoire de Bactériologie - CHU de Strasbourg - France
    Strasbourg, France
    Recruiting

Study contacts

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Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.