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Understanding Tick-borne Diseases (OHTICKS)

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ClinicalTrials.gov Identifier: NCT03501407
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur

Tracking Information
First Submitted Date March 30, 2018
First Posted Date April 18, 2018
Last Update Posted Date August 15, 2018
Actual Study Start Date June 1, 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 17, 2018)
Isolate new microorganisms—both unknown or unexpected—from patients suffering from unexplainable symptoms following tick bites [ Time Frame: up to 12 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03501407 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Understanding Tick-borne Diseases
Official Title One-Health Approach to Identify Threat Posed by Tick-borne Pathogens Responsible of Unexplained Infectious Syndrome in Humans
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood sample and skin biopsy
Sampling Method Non-Probability Sample
Study Population patient with and without an erythema migrans after ticks bite
Condition Lyme Disease
Intervention
  • 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
Study Groups/Cohorts
  • 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
    Interventions:
    • Diagnostic Test: Blood samples
    • Diagnostic Test: skin biopsy
  • 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

    Intervention: Diagnostic Test: Blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 17, 2018)
130
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: cecile Artaud +33144389241 cecile.artaud@pasteur.fr
Contact: Muriel Vayssier, PhD
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03501407
Other Study ID Numbers 2017-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Institut Pasteur
Study Sponsor Institut Pasteur
Collaborators Not Provided
Investigators
Principal Investigator: Catherine Chirouze, MD CHU BEsançon
PRS Account Institut Pasteur
Verification Date April 2018