Clinical trial NCT03501407: Understanding Tick-borne Diseases
Official title: One-Health Approach to Identify Threat Posed by Tick-borne Pathogens Responsible of Unexplained Infectious Syndrome in Humans
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lyme Disease
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with and without an erythema migrans after ticks bite

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.


Eligibility criteria: Inclusion Criteria for patient with an erythema migrans

* Age≥18 years
* Erythema migrans
* Registered with social security
* informed and written consent

Exclusion Criteria for patient with an erythema migrans

* Pregnant women
* Immunocompromised patients (undergoing chemotherapy, corticotherapy, or biotherapy)
* Chronic inflammatory disease
* Systemic disease

Inclusion Criteria for patient with no-erythema migrans:

* 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

Exclusion Criteria for patient with no-erythema migrans

* Pregnant women
* Immunocompromised patients (undergoing chemotherapy, corticotherapy, or biotherapy)
* Chronic inflammatory disease
* Systemic disease

Primary outcomes:
measure: Isolate new microorganisms-both unknown or unexpected-from patients suffering from unexplainable symptoms following tick bites
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
affiliation: CHU BEsançon
name: Catherine Chirouze, MD
role: PRINCIPAL_INVESTIGATOR
References: