Human AnaplasmosisANARETRONCT07312474
Epidemiological, Clinical and Biological Characteristics of Human Anaplasmosis Cases in Alsace
An observational study of Human Anaplasmosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Anaplasmosis is a bacterial infection caused by the intracellular bacterium Anaplasma phagocytophilum and transmitted by ticks. This bacterium is present in approximately 1% of ticks in Alsace. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Anaplasmosis
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2024to Feb 2026
- 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
- Adult, Older adult
Study population: Adult subjct (≥18 years) having a PCR-confirmed infection of Anaplasma
Who may be able to join
- Adult subjct (≥18 years)
- Presenting with a PCR-confirmed infection of Anaplasma
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
Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Strasbourg, 67091
Victor Gerber, MD, 33 3.88.11.67.68, victor.gerber@chru-strasbourg.frr
Victor Gerber, MD
About this study
Official title: Epidemiological, Clinical and Biological Characteristics of Human Anaplasmosis Cases in Alsace: a Retrospective and Multicenter Study
Anaplasmosis is a bacterial infection caused by the intracellular bacterium Anaplasma phagocytophilum and transmitted by ticks. This bacterium is present in approximately 1% of ticks in Alsace. This infection is responsible for clinical manifestations that are most often mild, including fever, headache, and myalgia, occurring 2 to 3 weeks after a tick bite. However, this infection can be accompanied by potentially serious or even fatal complications, including severe cytopenias, acute respiratory distress syndrome, septic shock, severe neurological disorders, hemorrhagic manifestations, macrophage activation syndrome, and multiple organ failure. Mortality is variable and appears to be higher in American studies, where it is around 4%. Treatment is well-established and relies on doxycycline, which is highly effective. Although a few cases have been described in France, these are mostly isolated cases or short series of cases, whereas Belgium, Poland, and Slovenia have reported numerous cases. Thus, there is a lack of data on French cases, and given that Alsace is in a region with a high prevalence of tick-borne diseases, data is needed to better understand the epidemiology and to better identify suspected cases in order to provide appropriate care.
- Conditions
- Human Anaplasmosis
- Keywords
- Human Anaplasmosis, Ticks, Tick bite, Severe cytopenias, Respiratory distress syndrome, Septic shock, Neurological disorders, Macrophage activation syndrome
- Medical subject headings
- Anaplasmosis, Tick Bites, Cytopenia, Respiratory Distress Syndrome, Shock, Septic, Nervous System Diseases, Macrophage Activation Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality of cases of human anaplasmosis in Alsace
Measured: Up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start2 Oct 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human AnaplasmosisStudies 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
- NCT07312474
- Sponsor's protocol ID
- 9458
- Acronym
- ANARETRO
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 31 Dec 2025
- 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 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological, Clinical and Biological Characteristics of Human Anaplasmosis Cases in Alsace: a Retrospective and Multicenter Study
- ClinicalTrials.gov ID
- NCT07312474
- Acronym / sponsor ID
- ANARETRO / 9458
- Conditions
- Human Anaplasmosis
- Keywords
- Human Anaplasmosis, Ticks, Tick bite, Severe cytopenias, Respiratory distress syndrome, Septic shock, Neurological disorders, Macrophage activation syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 31 Dec 2025 (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.
Anaplasmosis is a bacterial infection caused by the intracellular bacterium Anaplasma phagocytophilum and transmitted by ticks. This bacterium is present in approximately 1% of ticks in Alsace. This infection is responsible for clinical manifestations that are most often mild, including fever, headache, and myalgia, occurring 2 to 3 weeks after a tick bite. However, this infection can be accompanied by potentially serious or even fatal complications, including severe cytopenias, acute respiratory distress syndrome, septic shock, severe neurological disorders, hemorrhagic manifestations, macrophage activation syndrome, and multiple organ failure. Mortality is variable and appears to be higher in American studies, where it is around 4%. Treatment is well-established and relies on doxycycline, which is highly effective. Although a few cases have been described in France, these are mostly isolated cases or short series of cases, whereas Belgium, Poland, and Slovenia have reported numerous cases. Thus, there is a lack of data on French cases, and given that Alsace is in a region with a high prevalence of tick-borne diseases, data is needed to better understand the epidemiology and to better identify suspected cases in order to provide appropriate care.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult subjct (≥18 years) having a PCR-confirmed infection of Anaplasma
Key inclusion criteria (2 listed)
- Adult subjct (≥18 years)
- Presenting with a PCR-confirmed infection of Anaplasma
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
Mortality of cases of human anaplasmosis in Alsace
Time frame: Up to 12 years
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 31 Dec 2025.
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RecruitingObservational study
FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
Tick Borne Encephalitis (TBE), Lyme Borreliosis
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 Anaplasmosis, 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 2 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 31 Dec 2025. 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 3.88.11.67.68, 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?
Mortality of cases of human anaplasmosis in Alsace (time frame: Up to 12 years). 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 31 Dec 2025.