Understanding Tick-borne Diseases

Lyme Disease Clinical Trial

— OHTICKS  

Official title:

One-Health Approach to Identify Threat Posed by Tick-borne Pathogens Responsible of Unexplained Infectious Syndrome in Humans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03501407
• Other study ID #: 2017-002
• Status: Recruiting
• Start date: June 1, 2018
• Est. completion date: June 2020

Study information

• Verified date: April 2018
• Source: Institut Pasteur
• Contact: cecile Artaud
• Phone: +33144389241
• Email: cecile.artaud[@]pasteur.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lyme Disease

Intervention

Diagnostic Test:
• Blood samples
1 or 2 blood samples will be collected from the patient.
• skin biopsy
A skin biopsy will be performed on the periphery of the erythema migrans

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isolate new microorganisms—both unknown or unexpected—from patients suffering from unexplainable symptoms following tick bites		up to 12 months

External Links

•   Link