New test could speed up diagnosis of Tick-Borne disease
NCT ID NCT07307651
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will test a new RT-PCR method to diagnose Rickettsia infection, a tick-borne disease, using routine biopsy samples. Researchers will enroll 800 patients with suspected infection and compare the new test to standard methods. The goal is to see if the test can detect the infection earlier and more accurately.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to faster and more accurate diagnosis of Rickettsia infections, helping doctors start treatment sooner.
- What could go wrong
- This is an observational study, not a treatment trial. The new test may not prove more accurate than existing methods, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 800 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population will consist of patients belonging to the UUOOs involved in the study, for whom serum samples, whole blood, skin biopsy, eschar, vesicle buffer underlying the eschar collected through withdrawals that meet the inclusion criteria, performed according to clinical practice, are available: * For the retrospective cohort: from January 2023 until approval by the ethics committee; * For the prospective cohort: from ethics committee approval until December 2027. The Microbiology Unit is the operational reference unit. The Infectious Diseases and Dermatology Unit of the IRCCS AOUBO is involved in patient enrollment, as are the Hospitals and CAUs of the Bologna Local Health Authority, following requests for infectious disease counseling in the Bologna Metropolitan Area.
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * pazienti che presentano escara * pazienti con richiesta del dosaggio degli anticorpi anti-Rickettsia conorii Exclusion Criteria: * None
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AUSL di Bologna
Bologna, Bologna, Italy
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138, Italy
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