Understanding Tick-borne Diseases

NCT ID: NCT03501407

Last Updated: 2018-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lyme Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Blood samples

Intervention Type DIAGNOSTIC_TEST

1 or 2 blood samples will be collected from the patient.

skin biopsy

Intervention Type DIAGNOSTIC_TEST

A skin biopsy will be performed on the periphery of the erythema migrans

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

Blood samples

Intervention Type DIAGNOSTIC_TEST

1 or 2 blood samples will be collected from the patient.

Interventions

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Blood samples

1 or 2 blood samples will be collected from the patient.

Intervention Type DIAGNOSTIC_TEST

skin biopsy

A skin biopsy will be performed on the periphery of the erythema migrans

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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


* 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

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


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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Pasteur

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Catherine Chirouze, MD

Role: PRINCIPAL_INVESTIGATOR

CHU BEsançon

Locations

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Centre Hospitalier Universitaire

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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cecile Artaud

Role: CONTACT

+33144389241

Muriel Vayssier, PhD

Role: CONTACT

Facility Contacts

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Catherine Chirouze, MD

Role: primary

Related Links

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Other Identifiers

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2017-002

Identifier Type: -

Identifier Source: org_study_id

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