Borrelia InfectionsBorDiMabNCT07343089
A Multicenter Real-life Study of Disseminated Borreliosis Cases Occurring in Patients Receiving Anti-CD20 Treatment in France
An observational study of Borrelia Infections, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Clinical, biological, radiological, and pharmacological description of cases of disseminated borreliosis (Borrelia burgdorferi sl. and Borrelia miyamotoi) occurring in patients who received drug treatment based on anti-CD20 monoclonal antibodies. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Borrelia Infections
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2025to 29 Aug 2026
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient 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.
Who may be able to join
- 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.
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Laboratoire de Bactériologie - CHU de Strasbourg - France
Strasbourg, 67091
Pierre BOYER, MD, 33 3 69 55 14 69, pierre.boyer@chru-strasbourg.fr
Émilie TALAGRAND-REBOUL, MD, 33 3 69 55 14 57, Emilie.TALAGRANDREBOUL@chru-strasbourg.fr
About this study
Clinical, biological, radiological, and pharmacological description of cases of disseminated borreliosis (Borrelia burgdorferi sl. and Borrelia miyamotoi) occurring in patients who received drug treatment based on anti-CD20 monoclonal antibodies.
- Conditions
- Borrelia Infections
- Keywords
- Borreliosis, Lyme, Borrelia Infections, Borrelia Burgdorferi, Borrelia Miyamotoi, Anti-CD20 monoclonal antibodies
- Medical subject headings
- Borrelia Infections, Lyme Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the clinical presentation of cases of disseminated borreliosis occurring in patients receiving anti-CD20 therapy in France
The clinical presentation describes how the disease manifests in patients:
- the symptoms,
- their severity,
- and their progression.
Example:
Two patients may have the same disease, but one will primarily experience fever while the other will have neurological symptoms. This is part of the clinical presentation.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start29 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completion29 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borrelia InfectionsStudies 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
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343089
- Sponsor's protocol ID
- 9819
- Acronym
- BorDiMab
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No