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NCT Number: NCT06374615

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

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.

Recruiting

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Key information

Conditions

Tick-Borne Diseases Infections Vector Borne Diseases

Age range

8 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, 37024, Italy

Location status: Recruiting

Location contact

Andrea Tedesco

CONTACT

[email protected]

Andrea Tedesco

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all individuals aged > 8 years presenting for tick removal.
  • Individuals providing signed informed consent.

Exclusion criteria

  • tick not available for analysis

Treatment and study plan

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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Elvia Malo

CONTACT

[email protected]

+390456014854

Sponsors and collaborators

Lead sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Other

Registry information

Official study title

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

Acronym: TICKTOC

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Apr 18, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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