Human BabesiosisBABERETRONCT07345988
Human Babesiosis in Metropolitan France
An observational study of Human Babesiosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Babesiosis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2025to 4 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with a diagnosis of babesiosis confirmed by blood smear or PCR
Who may be able to join
- 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
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre de référence des maladies vectorielles à tiques, CNR Borrelia - CHU de Strasbourg - France
Strasbourg, 67091
Victor GERBER, MD, 33 3 68 85 37 97, victor.gerber@chru-strasbourg.frr
Victor GERBER, MD
About this study
Official title: 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.
- Conditions
- Human Babesiosis
- Keywords
- Human Babesiosis
- Medical subject headings
- Babesiosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the epidemiological, clinical, biological, and therapeutic characteristics of human babesiosis cases diagnosed in mainland France.
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.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start4 Nov 2025
- Primary completionMay 2027 (estimated)
- Study completion4 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human BabesiosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345988
- Sponsor's protocol ID
- 9947
- Acronym
- BABERETRO
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Babesiosis in Metropolitan France: a Retrospective and Multicenter Descriptive Analysis.
- ClinicalTrials.gov ID
- NCT07345988
- Acronym / sponsor ID
- BABERETRO / 9947
- Conditions
- Human Babesiosis
- Keywords
- Human Babesiosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- 4 May 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with a diagnosis of babesiosis confirmed by blood smear or PCR
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Related trials for Human Babesiosis
RecruitingObservational study
FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
Tick Borne Encephalitis (TBE), Lyme Borreliosis
RecruitingPhase 2
B-FREE Chronic Babesiosis Study
Chronic Babesiosis
RecruitingPhase 2
Oral Tafenoquine Plus Standard of Care Versus Placebo Plus Standard of Care for Babesiosis
Babesiosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Babesiosis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victor GERBER, MD (33 3 68 85 37 97, victor.gerber@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the epidemiological, clinical, biological, and therapeutic characteristics of human babesiosis cases diagnosed in mainland France. (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.