Human Babesiosis in Metropolitan France

NCT ID: NCT07345988

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-04

Study Completion Date

2027-05-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Human babesiosis is a rare zoonosis in Europe caused by protozoa of the genus Babesia, transmitted to humans mainly by ticks of the genus Ixodes. The infection mainly affects individuals who have undergone splenectomy, are immunocompromised, or are elderly, which correspond to the risk factors for the disease. The infection is often underdiagnosed due to its rarity and its often nonspecific clinical presentation (asthenia, fever, flu-like syndrome).

In these high-risk patients in particular, the infection can progress to severe forms, with a mortality rate of up to 20-40%. The clinical picture is then that of a severe infection with multiple organ failure: multifactorial renal failure, respiratory distress due to lesion edema, and disseminated intravascular coagulation. One of the main obstacles to understanding human babesiosis in France and Europe is the low number of cases recorded and published. This situation limits knowledge about the epidemiology of the disease, its clinical presentations, its potential severity, and the effectiveness of the treatments used.

The aim of this study is to describe the epidemiological, clinical, biological, therapeutic, and prognostic characteristics of human babesiosis cases diagnosed in metropolitan France.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Babesiosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult subjects (≥18 years old)
* With a diagnosis of babesiosis confirmed by blood smear or PCR
* Treated in associated centers during the period from January 1, 2000, to December 31, 2024

Exclusion Criteria

\- Refusal to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre de référence des maladies vectorielles à tiques, CNR Borrelia - CHU de Strasbourg - France

Strasbourg, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Victor GERBER, MD

Role: CONTACT

33 3 68 85 37 97

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Victor GERBER, MD

Role: primary

33 3 68 85 37 97

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

9947

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Human Immune Response to Ixodes Scapularis Tick Bites
NCT05036707 RECRUITING PHASE1/PHASE2
Erythema Migrans in Elderly
NCT03371563 COMPLETED
Phase 1/2 Lyme Vaccine Study
NCT01504347 COMPLETED PHASE1/PHASE2