Understanding Tick-borne Diseases
OHTICKS
One-Health Approach to Identify Threat Posed by Tick-borne Pathogens Responsible of Unexplained Infectious Syndrome in Humans
1 other identifier
observational
130
1 country
1
Brief Summary
Ticks are the major arthropod vectors transmitting pathogenic agents to humans and domestic animals in Europe, and currently, the incidence of tick-borne disease is rising. The most common European human tick-borne disease is Lyme borreliosis, with an estimated 90 000 new cases every year (compared to 300 000 new cases in the United States annually). This disease is initially clinically diagnosed by the presence of migrating erythema following a tick bite, which is then subsequently confirmed by serological tests. In parallel with classic Lyme borreliosis cases, tick-bitten patients can also present with polymorphic and on-specific clinical symptoms (asthenia, fever, myalgia, etc. …) for which there is no known etiological diagnosis. It is extremely difficult to determine the proportion of tick-bitten patients with these symptoms compared to patients which have actually contracted Lyme disease, although it is estimated that 50% of fevers following a tick bite have an unknown infectious origin. Typical tick habitats are woodlands, prairies, pastures, and gardens. Ticks are extremely sensitive to environmental fluctuations, which are often brought about by human socio-economic changes, thus tick-borne diseases are excellent candidates for emergence. Consequently, it is incontestable that tickborne diseases pose a significant threat to our society. In addition to improving diagnostic techniques, one of the major hurdles relates to improving public and health professional knowledge about tick disease risk. The battle against tick-borne diseases is based on relatively simple prevention measures, and their effectiveness is immeasurably improved when citizens are more informed and involved.Therefore, a multidisciplinary project, bringing together veterinarians, doctors, scientists, and consultant sociologists has been designed to create a global "One Health" approach to tick-borne diseases. Specific scientific project objectives are to (1) detect, identify, and isolate new microorganisms-both unknown or unexpected-from patients or animals suffering from unexplainable symptoms following tick bites; (2) to demonstrate tick competence in their ability to transmit these agents; and (3) to generate concrete recommendations to improve tick-borne disease management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedAugust 15, 2018
April 1, 2018
1 year
March 30, 2018
August 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Isolate new microorganisms-both unknown or unexpected-from patients suffering from unexplainable symptoms following tick bites
up to 12 months
Study Arms (2)
Erythema migrans
Patients for whom a diagnosis of acute phase of Lyme disease is done on the basis of the existence of an erythema migrans and a tick bite history in the days preceding the occurrence of erythema (before and after antibiotics treatment) will be recruited
No-erythema migrans
Patients with unspecific symptoms (the most common symptoms being: headache, arthralgia, myalgia, febrile episode) appearing within 3 months after a tick bite will be recruited
Interventions
1 or 2 blood samples will be collected from the patient.
A skin biopsy will be performed on the periphery of the erythema migrans
Eligibility Criteria
patient with and without an erythema migrans after ticks bite
You may qualify if:
- Age≥18 years
- Erythema migrans
- Registered with social security
- informed and written consent
You may not qualify if:
- Pregnant women
- Immunocompromised patients (undergoing chemotherapy, corticotherapy, or biotherapy)
- Chronic inflammatory disease
- Systemic disease
- Age≥18 years
- Confirmed tick bite within the last 6 months prior to the appearance of inflammatory joint disease verified via joint imaging (MRI or ultrasound)
- and/or cerebrospinal fluid cyto-chemical anomalies (meningitis,albuminocytological dissociation)
- Registered with social security
- informed and written consent
- Pregnant women
- Immunocompromised patients (undergoing chemotherapy, corticotherapy, or biotherapy)
- Chronic inflammatory disease
- Systemic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Pasteurlead
Study Sites (1)
Centre Hospitalier Universitaire
Besançon, 25030, France
Related Links
Biospecimen
blood sample and skin biopsy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Chirouze, MD
CHU BEsançon
Central Study Contacts
Muriel Vayssier, PhD
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2018
First Posted
April 18, 2018
Study Start
June 1, 2018
Primary Completion
June 1, 2019
Study Completion
June 1, 2020
Last Updated
August 15, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share