Disseminated Lyme and Borrelia miyamotoi infections after anti‑CD20 treatment in France
A Multicenter Real-life Study of Disseminated Borreliosis Cases Occurring in Patients Receiving Anti-CD20 Treatment in France
This project looks at clinical, laboratory, imaging, and medication information from people in France who developed widespread Borrelia infections after anti‑CD20 therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT07343089 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Case reports and small case series have described Borrelia infections after anti‑CD20 therapy, but comprehensive multicenter descriptive data are limited.
Eligibility criteria
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 this trial is running
Strasbourg
- Laboratoire de Bactériologie - CHU de Strasbourg - France — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Pierre BOYER, MD
- Email: pierre.boyer@chru-strasbourg.fr
- Phone: 33 3 69 55 14 69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.