Insights Into Tick-Borne Diseases: a Study From an Endemic Area of Northern Italy
NCT ID: NCT06374615
Last Updated: 2024-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
384 participants
INTERVENTIONAL
2024-03-25
2029-03-31
Brief Summary
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The study is experimental because all the visits and blood withdrawals foreseen by the protocol do not fall within the normal clinical practice.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Serological test for Tick-borne Patogens
A baseline visit (T0) will be scheduled within 7-10 days of the tick bite. T0 visit will include: signature of ICF, data collection, blood sampling. Signature of a specific consent will be sought for storage of the leftover samples at -80°.
12 weeks apart from the bite (T1), subjects will be invited to a clinical and serological follow-up visit.
Participants will be taught to contact the study investigators in case of emergence of compatible signs/symptoms. In this case, one of the study members will call the participant to schedule an additional visit (T unscheduled, TU). At this time a blood sample will be collected. Timing for molecular and serological tests will be performed in relation to the emergence of patient's symptoms. In case of TBDs caused by TBEV, Rickettsia spp, Borrelia spp, Ehrlichia, Anaplasma spp. and Babesia spp the patient will be treated according to standard clinical practice.
IgG 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.
Interventions
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IgG 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.
Eligibility Criteria
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Inclusion Criteria
* Individuals providing signed informed consent.
Exclusion Criteria
8 Years
ALL
No
Sponsors
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IRCCS Sacro Cuore Don Calabria di Negrar
OTHER
Responsible Party
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Locations
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IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-07
Identifier Type: -
Identifier Source: org_study_id
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