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

Not Applicable

Recruiting

• Conditions: Tick-Borne Diseases

• Registration Number: NCT06374615
• Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-25
• Status Verified: 2024-04
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-18
• Last Update Posted: 2024-04-18
• Primary Completion: 2029-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 384

Inclusion Criteria

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

Exclusion Criteria

• tick not available for analysis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	baseline

Secondary Outcome Measures

Name	Time	Method
Number of identified Tick-Borne Patogenees (TBPs) on the total number of analyzed ticks	baseline
Number of individuals who developed specific antibodies against a TBP after tick bite.	12 weeks
List of novel TBPs that were not previously found in the study areas.	baseline
Number of individuals who developed symptoms and were diagnosed for a TBP infection during the 12 weeks' follow-up period	12 weeks

Trial Locations

Locations (1)

IRCCS Sacro Cuore Don Calabria hospital; 🇮🇹 Negrar, Verona, Italy