Actively Recruiting

Phase Not Applicable
Age: 8Years +
All Genders
ID06374615

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

Led by IRCCS Sacro Cuore Don Calabria di Negrar · Updated on 2024-04-18

384

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting an experimental, non-drug and non-device study focused on tick-borne diseases in a region of Northern Italy where these infections are common. The purpose is to monitor and analyze individuals who have been bitten by ticks to better understand the infections transmitted by ticks and their impact. This monocentric study involves detailed visits and blood sampling that go beyond usual medical care practices. Participants will have an initial visit within 7 to 10 days after a tick bite, which includes signing consent forms, collecting data, and drawing blood samples. A follow-up visit occurs 12 weeks later to assess clinical and serological changes. If symptoms suggestive of tick-borne diseases appear, participants will have an additional unscheduled visit with further blood collection. If infections like TBEV, Rickettsia, Borrelia, Ehrlichia, Anaplasma, or Babesia are diagnosed, treatment will follow standard medical guidelines. Throughout the study, participants will undergo blood tests to detect antibodies and molecular testing on ticks and blood samples to identify specific tick-borne pathogens. Researchers will track how many people develop infections and antibodies during the 12-week follow-up. The study includes monitoring symptoms and collecting leftover samples stored at very low temperatures. Participation involves multiple visits and tests over about three months with careful monitoring of health and laboratory results.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 8Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals aged over 8 years presenting for tick removal
  • Individuals providing signed informed consent
Not Eligible

You will not qualify if you...

  • Tick not available for analysis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) within 7-10 days of the tick bite

Diagnostic Evaluation

Duration - Up to 12 weeks

Participants undergo blood sampling and tick analysis to test for the presence of specific tick-borne pathogens.

1 baseline visit and 1 follow-up visit at 12 weeks apart

Long-term Monitoring

Duration - Up to 12 weeks post baseline

Participants are monitored for emergence of symptoms and additional blood samples may be collected if symptoms develop.

Additional unscheduled visit(s) if symptoms develop

Trial Site Locations

Total: 1 location

1

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, Italy, 37024

Actively Recruiting

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Research Team

E

Elvia Malo

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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