Understanding Tick-borne Diseases (OHTICKS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03501407|
Recruitment Status : Not yet recruiting
First Posted : April 18, 2018
Last Update Posted : April 18, 2018
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.
|Condition or disease||Intervention/treatment|
|Lyme Disease||Diagnostic Test: Blood samples Diagnostic Test: skin biopsy|
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||One-Health Approach to Identify Threat Posed by Tick-borne Pathogens Responsible of Unexplained Infectious Syndrome in Humans|
|Estimated Study Start Date :||June 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
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
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.
- Isolate new microorganisms—both unknown or unexpected—from patients suffering from unexplainable symptoms following tick bites [ Time Frame: up to 12 months ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501407
|Contact: cecile Artaudfirstname.lastname@example.org|
|Contact: Muriel Vayssier, Dr|