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

Tick-Borne Diseases Clinical Trial

— TICKTOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06374615
• Other study ID #: 2024-07
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: March 2029

Study information

• Verified date: April 2024
• Source: IRCCS Sacro Cuore Don Calabria di Negrar
• Contact: Elvia Malo
• Phone: +390456014854
• Email: ricerca.clinica[@]sacrocuore.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: March 2029
• Est. primary completion date: March 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• all individuals aged > 8 years presenting for tick removal.

• Individuals providing signed informed consent.

Exclusion Criteria:

• tick not available for analysis

Related Conditions & MeSH terms

• Tick-Borne Diseases

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Sacro Cuore Don Calabria hospital	Negrar	Verona

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Sacro Cuore Don Calabria di Negrar

Country where clinical trial is conducted

Italy, 

Outcome

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