About this trial
This is a monocentric, experimental, non-pharmacological and non-device no profit study.
The study is experimental because all the visits and blood withdrawals foreseen by the protocol do not fall within the normal clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
all individuals aged > 8 years presenting for tick removal.
Individuals providing signed informed consent.
Disqualifiers
tick not available for analysis
Trial design
Single group
Treatments tested in this trial
IgG and IgM search for specific Tick-Borne Patogens
Diagnostic testTicks will be classified based on morphological characteristics by microscopy observation. For TBP detection by molecular test, Nucleic acid extraction will be performed on ticks lysate or blood using kits MagMAX TM Viral/Pathogen Nucleic Acid Isolation Kit (Thermo Fisher Scientific) on MagEX STARlet platform from Hamilton. Species identification by molecular method will be performed by Sanger sequencing for Rickettsiae and Babesia, and Multi-Locus Sequence Typing will be used to characterize Borrelia. Serum samples collected throughout the study will be tested to assess any seroconversions during the follow-up period. Samples will be tested for the presence of specific IgG and IgM for the following TBPs: TBEV, R. typhi. R. conorii, Borrelia spp, Anaplasma, Ehrlichia and Babesia.
Treatment groups
Trial outcomes
Primary outcomes
Number of individuals diagnosed with Tick-Borne Diseases (TBD) over the total number of individuals who were bitten by a tick which carried an identified TBP.
Secondary outcomes
Number of identified Tick-Borne Patogenees (TBPs) on the total number of analyzed ticks
Number of individuals who developed symptoms and were diagnosed for a TBP infection during the 12 weeks' follow-up period
Number of individuals who developed specific antibodies against a TBP after tick bite.
List of novel TBPs that were not previously found in the study areas.
Sponsors and contacts
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