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

April 16, 2024 updated by: IRCCS Sacro Cuore Don Calabria di Negrar

Insights Into Tick-Borne Diseases: a Prospective 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

384

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Verona
      • Negrar, Verona, Italy, 37024
        • Recruiting
        • IRCCS Sacro Cuore Don Calabria hospital
        • Contact:
        • Principal Investigator:
          • Andrea Tedesco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • tick not available for analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Serological test for Tick-borne Patogens

A baseline visit (T0) will be scheduled within 7-10 days of the tick bite. T0 visit will include: signature of ICF, data collection, blood sampling. Signature of a specific consent will be sought for storage of the leftover samples at -80°.

12 weeks apart from the bite (T1), subjects will be invited to a clinical and serological follow-up visit.

Participants will be taught to contact the study investigators in case of emergence of compatible signs/symptoms. In this case, one of the study members will call the participant to schedule an additional visit (T unscheduled, TU). At this time a blood sample will be collected. Timing for molecular and serological tests will be performed in relation to the emergence of patient's symptoms. In case of TBDs caused by TBEV, Rickettsia spp, Borrelia spp, Ehrlichia, Anaplasma spp. and Babesia spp the patient will be treated according to standard clinical practice.
Diagnostic test: IgG and IgM search for specific Tick-Borne Patogens

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Sacro Cuore Don Calabria di Negrar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2024

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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