Visceral Leishmaniasis in Emilia-Romagna (Leishmania-2019) (NCT06793111) | Clinical Trial Compass
RecruitingNot Applicable
Visceral Leishmaniasis in Emilia-Romagna (Leishmania-2019)
Italy300 participantsStarted 2020-04-21
Plain-language summary
According to reports in the literature, from 2012 to date, there has been an increase in the number of diagnosed cases of autochthonous visceral Leishmania in the Province of Bologna.
In this context, it was decided to carry out a retrospective prospective observational study, which is essential to describe the epidemiology of LV in order to outline the scientific and rational bases necessary for the drafting of guidelines to standardise the diagnostic and therapeutic approach to this disease, in order to reduce the diagnostic delay and improve therapeutic results.
therapeutic outcome. In addition, epidemiological data will make it possible to identify possible new strategies to control the disease, which are essential for reducing its transmission.
Who can participate
Age range
6 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients of any age with microbiologically established diagnosis of LV.
* Obtaining Informed Consent.
Exclusion Criteria:
* not having obtained Informed Consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is focused on collecting epidemiological and clinical data about Visceral Leishmaniasis cases in the Emilia-Romagna region, can you explain what my actual involvement would look like — for example, would I just be providing information and medical records, or would there be additional tests or visits beyond my normal care?
2This trial is listed as 'Phase NA,' which usually means it's an observational or registry study rather than a treatment trial — so can you clarify whether joining this study would change my treatment plan at all, or whether I'd still receive the same standard therapies for Visceral Leishmaniasis?
3Given that this study is specifically tracking cases in Emilia-Romagna, does my own location or where I was diagnosed affect whether this study is relevant to me, and would my data still be useful if I'm being treated at a different center?
4The study is collecting socio-demographic and clinical characteristics of VL patients — can you tell me what personal health information would be shared, who would have access to it, and how my privacy would be protected?
5Since this appears to be a data-collection study rather than a trial testing a new treatment, would it be worth asking whether there are any active treatment trials for Visceral Leishmaniasis that might also be worth considering alongside or instead of this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Epidemiology of Visceral Leishmaniasis (VL) cases in Emilia-Romagna
Timeframe: March 2020 - February 2025
2
Socio-demographic and clinical characteristics of patients diagnosed with VL
Timeframe: March 2020 - February 2025
Trial details
NCT IDNCT06793111
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna