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Trial record 34 of 73 for:    lyme

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

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.


Condition or disease Intervention/treatment
Lyme Disease Diagnostic Test: Blood samples Diagnostic Test: skin biopsy

Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: One-Health Approach to Identify Threat Posed by Tick-borne Pathogens Responsible of Unexplained Infectious Syndrome in Humans
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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
blood sample and skin biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patient with and without an erythema migrans after ticks bite
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

Information from the National Library of Medicine

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


Contacts
Contact: cecile Artaud +33144389241 cecile.artaud@pasteur.fr
Contact: Muriel Vayssier, PhD

Locations
France
Centre Hospitalier Universitaire Recruiting
Besançon, France, 25030
Contact: Catherine Chirouze, MD         
Sponsors and Collaborators
Institut Pasteur
Investigators
Principal Investigator: Catherine Chirouze, MD CHU BEsançon

Additional Information:
Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT03501407     History of Changes
Other Study ID Numbers: 2017-002
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Spirochaetales Infections