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

NCT06374615 | Recruiting

• 1 other identifier: 2024-07
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

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.

Conditions

Tick-Borne Diseases

Outcome Measures

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.

  baseline

Secondary Outcomes (4)

• Number of identified Tick-Borne Patogenees (TBPs) on the total number of analyzed ticks

  baseline

• Number of individuals who developed symptoms and were diagnosed for a TBP infection during the 12 weeks' follow-up period

  12 weeks

• 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

Study Arms (1)

Serological test for Tick-borne Patogens

EXPERIMENTAL

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

Interventions

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.

Serological test for Tick-borne Patogens

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• tick not available for analysis

Sponsors & Collaborators

• IRCCS Sacro Cuore Don Calabria di Negrar: lead

Study Sites (1)

IRCCS Sacro Cuore Don Calabria hospital

Negrar, Verona, 37024, Italy

RECRUITING

MeSH Terms

Conditions

Tick-Borne Diseases

Condition Hierarchy (Ancestors)

Vector Borne Diseases; Infections

Central Study Contacts

Elvia Malo

CONTACT

+390456014854; ricerca.clinica@sacrocuore.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 18, 2024
• Study Start: March 25, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

IT (1)