Tick-Borne Diseases
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTIgG and IgM search for specific Tick-Borne Patogens
Ticks 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.
Sponsors
IRCCS Sacro Cuore Don Calabria di Negrar
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* all individuals aged \> 8 years presenting for tick removal. * Individuals providing signed informed consent.
Exclusion criteria
* tick not available for analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | baseline |
Secondary
| Measure | Time frame |
|---|---|
| Number of identified Tick-Borne Patogenees (TBPs) on the total number of analyzed ticks | baseline |
| Number of individuals who developed symptoms and were diagnosed for a TBP infection during the 12 weeks' follow-up period | 12 weeks |
| Number of individuals who developed specific antibodies against a TBP after tick bite. | 12 weeks |
| List of novel TBPs that were not previously found in the study areas. | baseline |
Countries
Italy
Contacts
Primary ContactElvia Malo
Outcome results
None listed