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NCT Number: NCT07345988

Human Babesiosis in Metropolitan France

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Aurélie OUZOULIAS, MD

PRINCIPAL_INVESTIGATOR

Thibault GOETSCH, Statistician

SUB_INVESTIGATOR

Victor GERBER, MD

CONTACT

[email protected]

33 3 68 85 37 97

Victor GERBER, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Victor GERBER, MD

CONTACT

[email protected]

33 3 68 85 37 97

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: BABERETRO

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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