Human Babesiosis in Metropolitan France (BABERETRO)

January 7, 2026 updated by: University Hospital, Strasbourg, France

Human Babesiosis in Metropolitan France: a Retrospective and Multicenter Descriptive Analysis.

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Centre de référence des maladies vectorielles à tiques, CNR Borrelia - CHU de Strasbourg - France
        • Principal Investigator:
          • Victor GERBER, MD
        • Contact:
        • Principal Investigator:
          • Aurélie OUZOULIAS, MD
        • Sub-Investigator:
          • Thibault GOETSCH, Statistician

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult subjects with a diagnosis of babesiosis confirmed by blood smear or PCR

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the epidemiological, clinical, biological, and therapeutic characteristics of human babesiosis cases diagnosed in mainland France.
Time Frame: Up to 18 months
This study does not include any evaluation; it simply describes the epidemiological, clinical, biological, and therapeutic characteristics of human babesiosis cases diagnosed in mainland France.
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 4, 2027

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9947 (CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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