Insights Into Tick-Borne Diseases: a Study From an Endemic Area of Northern Italy
Not Applicable
Recruiting
- Conditions
- Tick-Borne Diseases
- Interventions
- Diagnostic Test: IgG and IgM search for specific Tick-Borne Patogens
- 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
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
- Arm && Interventions
Group Intervention Description Serological test for Tick-borne Patogens IgG and IgM search for specific 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.
- 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