NCT06374615

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-25
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2024-04-18
• Last updated: 2024-04-18

Locations

1 site across 1 country: Italy