Insights Into Tick-Borne Diseases: a Study From an Endemic Area of Northern Italy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8+
SponsorIRCCS Sacro Cuore Don Calabria di Negrar

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 volunteers

Qualifiers

all individuals aged > 8 years presenting for tick removal.

Individuals providing signed informed consent.

Disqualifiers

tick not available for analysis

Trial design

Design model

Single group

Treatments tested in this trial

  • IgG and IgM search for specific Tick-Borne Patogens

    Diagnostic test

    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.

Treatment groups

384 Participants
are divided into 1 treatment group
Group A: Serological test for Tick-borne PatogensExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline

Secondary outcomes

1

Number of identified Tick-Borne Patogenees (TBPs) on the total number of analyzed ticks

Time frame
baseline
2

Number of individuals who developed symptoms and were diagnosed for a TBP infection during the 12 weeks' follow-up period

Time frame
12 weeks
3

Number of individuals who developed specific antibodies against a TBP after tick bite.

Time frame
12 weeks
4

List of novel TBPs that were not previously found in the study areas.

Time frame
baseline

Other outcomes

Sponsors and contacts

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