Understanding Tick-borne Diseases (OHTICKS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Lyme Disease
• Intervention / Treatment: Diagnostic test: Blood samples; Diagnostic test: skin biopsy

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

• Study Contact: Name: cecile Artaud; Phone Number: +33144389241; Email: cecile.artaud@pasteur.fr
• Study Contact Backup: Name: Muriel Vayssier, PhD

Study Locations

• France
  • Besançon, France, 25030
    • Recruiting
    • Centre Hospitalier Universitaire
    • Contact: Catherine CHIROUZE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patient with and without an erythema migrans after ticks bite

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: Blood samples; 1 or 2 blood samples will be collected from the patient.; Diagnostic test: skin biopsy; 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	Diagnostic test: Blood samples; 1 or 2 blood samples will be collected from the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Isolate new microorganisms-both unknown or unexpected-from patients suffering from unexplainable symptoms following tick bites	up to 12 months

Collaborators and Investigators

• Sponsor: Institut Pasteur
• Investigators: Principal Investigator: Catherine Chirouze, MD, CHU Besançon

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: March 30, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Tick-Borne Diseases; Borrelia Infections; Spirochaetales Infections; Lyme Disease
• Other Study ID Numbers: 2017-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No