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

NCT06374615 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2024-04-18

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • IRCCS Sacro Cuore Don Calabria di Negrar

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-25
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06374615 on ClinicalTrials.gov