Recruiting NCT06374615
Insights Into Tick-Borne Diseases: a Study From an Endemic Area of Northern Italy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IgG and IgM search for specific Tick-Borne Patogens.
- Who it may be relevant to
- Registry conditions: Tick-Borne Diseases. Basic parameters: from 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Insights Into Tick-Borne Diseases: a Prospective Study From an Endemic Area of Northern Italy
Overview
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.
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 B
Primary outcome measures
- 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. [Time frame: baseline]
Secondary outcome measures (4)
- Number of identified Tick-Borne Patogenees (TBPs) on the total number of analyzed ticks [Time frame: baseline]
- Number of individuals who developed symptoms and were diagnosed for a TBP infection during the 12 weeks' follow-up period [Time frame: 12 weeks]
- Number of individuals who developed specific antibodies against a TBP after tick bite. [Time frame: 12 weeks]
- List of novel TBPs that were not previously found in the study areas. [Time frame: baseline]
Eligibility criteria
Inclusion criteria
- all individuals aged > 8 years presenting for tick removal.
- Individuals providing signed informed consent.
Exclusion criteria
- tick not available for analysis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- IRCCS Sacro Cuore Don Calabria hospital — Negrar
Identifiers
NCT: NCT06374615 · 2024-07