Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Individuals aged over 8 years presenting for tick removal
- Individuals providing signed informed consent
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
Your Study Journey
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
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
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
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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