NCT07343089

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Aug 2025Aug 2026

Study Start

First participant enrolled

August 29, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2026

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 6, 2026

Last Update Submit

January 6, 2026

Conditions

Borrelia Infections

Keywords

Borreliosis, LymeBorrelia InfectionsBorrelia BurgdorferiBorrelia MiyamotoiAnti-CD20 monoclonal antibodies

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 12 months

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire de Bactériologie - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Borrelia InfectionsLyme Disease

Condition Hierarchy (Ancestors)

Spirochaetales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsTick-Borne DiseasesVector Borne Diseases

Central Study Contacts

Pierre BOYER, MD

CONTACT

33 3 69 55 14 69pierre.boyer@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 15, 2026

Study Start

August 29, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 29, 2026

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

FR(1)