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

IRCCS Sacro Cuore Don Calabria di Negrar

Status: Enrolling

Conditions: Tick-Borne Diseases

Treatments: Diagnostic Test: IgG and IgM search for specific Tick-Borne Patogens

Study type: Interventional

Funder types: Other

Identifiers

NCT06374615

2024-07

Details and patient eligibility

About

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.

Enrollment: 384 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• tick not available for analysis

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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384 participants in 1 patient group

Serological test for Tick-borne Patogens

Experimental group

Description:

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.

Treatment:

Diagnostic Test: IgG and IgM search for specific Tick-Borne Patogens