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Recruiting NCT07345988

Human Babesiosis in Metropolitan France

Observational Human Babesiosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Human Babesiosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Description of the epidemiological, clinical, biological, and therapeutic characteristics of human babesiosis cases diagnosed in mainland France. [Time frame: Up to 18 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Centre de référence des maladies vectorielles à tiques, CNR Borrelia - CHU de Strasbourg - — Strasbourg

Identifiers

NCT: NCT07345988 · 9947

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗