Lyme BorreliosisPREFORTICNCT06492668
Risk of Exposure and Prevention of Ticks and Tick-borne Diseases Among Foresters in Alsace
An observational study of Lyme Borreliosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Ticks are blood-sucking arthropods that feed on vertebrate hosts. Although wild and domestic animals are the primary source of tick blood meals, humans can be an accidental host. During a blood meal, a microorganism can be transmitted to the host who can develop a disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lyme Borreliosis
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2024to 8 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Major forester (≥18 years old), ONF (National Forestry Office) staff regularly exposed to ticks in Alsace.
Who may be able to join
- Major forester (≥18 years old)
- Male or female gender
- ONF (National Forestry Office) staff
- Regularly exposed to ticks in Alsace (exclusively)
- Practicing regular forestry activities in a group
- Agreeing to participate in the study.
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre National de Référence Borrelia - CHU de Strasbourg - France
Strasbourg, Les Hôpitaux Universitaires de Strasbourg, 67091
Nathalie BOULANGER, PUPH, 33 3 69 55 14 49, nathalie.boulanger@chru-strasbourg.fr
Nathalie BOULANGER, PUPH
About this study
Official title: Risk of Exposure and Prevention of Ticks and Tick-borne Diseases Among Foresters in Alsace (France)
Ticks are blood-sucking arthropods that feed on vertebrate hosts. Although wild and domestic animals are the primary source of tick blood meals, humans can be an accidental host. During a blood meal, a microorganism can be transmitted to the host who can develop a disease. All infectious diseases transmitted by ticks are referred to as tick-borne diseases (TBDs). They are the most prevalent vector-borne diseases in the Northern Hemisphere. Among these diseases, Lyme borreliosis is the most common.
In Europe, Lyme borreliosis does not cause high fevers (> 38°C). Therefore, when a patient presents with a high fever with the notion of exposure to ticks, another etiology must be suspected. Anaplasma phagocytophilum and the tick-borne encephalitis virus are classically described as causing febrile syndromes.
In France, ticks and tick-borne diseases are increasing, particularly those associated with the Ixodes ricinus tick. This tick is mainly present in forest ecosystems with a peak of activity in May. Foresters represent a population with biting ticks and tick-borne diseases, notably Lyme borreliosis.
- Conditions
- Lyme Borreliosis
- Keywords
- Tick-Borne Diseases, Lyme borreliosis, Febrile syndromes, Ixodes ricinus tick
- Medical subject headings
- Lyme Disease, Tick-Borne Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ticks found on clothing during activities in forest ecosystems, and if tick bites, their number.
This study is carried out on foresters in the Alsacce region over a period of one year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Jan 2024
- Primary completionJul 2025 (estimated)
- Study completion8 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme BorreliosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 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
- NCT06492668
- Sponsor's protocol ID
- 9309
- Acronym
- PREFORTIC
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 15 Jul 2024
- 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 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Exposure and Prevention of Ticks and Tick-borne Diseases Among Foresters in Alsace (France)
- ClinicalTrials.gov ID
- NCT06492668
- Acronym / sponsor ID
- PREFORTIC / 9309
- Conditions
- Lyme Borreliosis
- Keywords
- Tick-Borne Diseases, Lyme borreliosis, Febrile syndromes, Ixodes ricinus tick
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- 8 Jul 2025 (estimated)
- First posted
- 9 Jul 2024 (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.
Ticks are blood-sucking arthropods that feed on vertebrate hosts. Although wild and domestic animals are the primary source of tick blood meals, humans can be an accidental host. During a blood meal, a microorganism can be transmitted to the host who can develop a disease. All infectious diseases transmitted by ticks are referred to as tick-borne diseases (TBDs). They are the most prevalent vector-borne diseases in the Northern Hemisphere. Among these diseases, Lyme borreliosis is the most common.
In Europe, Lyme borreliosis does not cause high fevers (> 38°C). Therefore, when a patient presents with a high fever with the notion of exposure to ticks, another etiology must be suspected. Anaplasma phagocytophilum and the tick-borne encephalitis virus are classically described as causing febrile syndromes.
In France, ticks and tick-borne diseases are increasing, particularly those associated with the Ixodes ricinus tick. This tick is mainly present in forest ecosystems with a peak of activity in May. Foresters represent a population with biting ticks and tick-borne diseases, notably Lyme borreliosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major forester (≥18 years old), ONF (National Forestry Office) staff regularly exposed to ticks in Alsace.
Key inclusion criteria (6 listed)
- Major forester (≥18 years old)
- Male or female gender
- ONF (National Forestry Office) staff
- Regularly exposed to ticks in Alsace (exclusively)
- Practicing regular forestry activities in a group
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
Number of ticks found on clothing during activities in forest ecosystems, and if tick bites, their number.
Time frame: 1 year
This study is carried out on foresters in the Alsacce region over a period of one year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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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. This study is not recruiting at the moment.
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 Lyme Borreliosis, 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 6 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: status not confirmed, as of the sponsor's last update on 15 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie BOULANGER, PUPH (03 69 55 14 49, nathalie.boulanger@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ticks found on clothing during activities in forest ecosystems, and if tick bites, their number. (time frame: 1 year). 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 15 Jul 2024.