Tick-Borne DiseasesTICKTOCNCT06374615
Insights Into Tick-Borne Diseases: a Study From an Endemic Area of Northern Italy
A study testing IgG and IgM search for specific Tick-Borne Patogens in people with Tick-Borne Diseases, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Tick-Borne Diseases
- What is being tested?
- IgG and IgM search for specific Tick-Borne Patogens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 1 siteItaly
- Study dates
- 25 Mar 2024to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all individuals aged > 8 years presenting for tick removal.
- Individuals providing signed informed consent.
Who cannot join
- tick not available for analysis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Sacro Cuore Don Calabria hospital
Negrar, Verona, 37024
Andrea Tedesco, andrea.tedesco@sacrocuore.it
Andrea Tedesco
About this study
Official title: Insights Into Tick-Borne Diseases: a Prospective Study From an Endemic Area of Northern Italy
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
- Being tested
- IgG and IgM search for specific Tick-Borne Patogens
- Medical subject headings
- Tick-Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IgG and IgM search for specific Tick-Borne PatogensDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Serological test for Tick-borne Patogens | Experimental | 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. Receives: Diagnostic Test: IgG and IgM search for specific Tick-Borne Patogens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Secondary outcomes (4)
Number of identified Tick-Borne Patogenees (TBPs) on the total number of analyzed ticks
Measured: baseline
Number of individuals who developed symptoms and were diagnosed for a TBP infection during the 12 weeks' follow-up period
Measured: 12 weeks
Number of individuals who developed specific antibodies against a TBP after tick bite.
Measured: 12 weeks
List of novel TBPs that were not previously found in the study areas.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start25 Mar 2024
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tick-Borne DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di Negrar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374615
- Sponsor's protocol ID
- 2024-07
- Acronym
- TICKTOC
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insights Into Tick-Borne Diseases: a Prospective Study From an Endemic Area of Northern Italy
- ClinicalTrials.gov ID
- NCT06374615
- Acronym / sponsor ID
- TICKTOC / 2024-07
- Conditions
- Tick-Borne Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- IRCCS Sacro Cuore Don Calabria di NegrarUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serological test for Tick-borne Patogens | Experimental | Diagnostic Test: IgG and IgM search for specific Tick-Borne PatogensA 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- all individuals aged > 8 years presenting for tick removal.
- Individuals providing signed informed consent.
Key exclusion criteria (1 listed)
- tick not available for analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IgG and IgM search for specific Tick-Borne PatogensTicks 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. | Diagnostic test | Serological test for Tick-borne Patogens |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IgG and IgM search for specific Tick-Borne Patogens in people with Tick-Borne Diseases, run by IRCCS Sacro Cuore Don Calabria di Negrar at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elvia Malo (+390456014854, ricerca.clinica@sacrocuore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.