Actively Recruiting
Visceral Leishmaniasis in Emilia-Romagna Region: Observational Study of Epidemiology and Clinical Characteristics
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-27
300
Participants Needed
5
Research Sites
30 weeks
Total Duration
On this page
Sponsors
I
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Lead Sponsor
A
AUSL Romagna Rimini
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to understand the spread and characteristics of visceral Leishmaniasis (LV) in the Emilia-Romagna region, where cases have increased since 2012. This disease is caused by Leishmania parasites and affects various animals and humans, with significant health impacts worldwide. The study aims to provide scientific data to support guidelines for diagnosis and treatment, reduce delays in diagnosis, and improve therapy outcomes. It also seeks to explore new ways to control the disease and reduce its transmission. The study is retrospective and prospective, gathering data from patients diagnosed with visceral Leishmaniasis between March 2020 and February 2025. It involves observing the epidemiology, socio-demographic and clinical features of patients, and evaluating the accuracy of diagnostic methods. The study also monitors how well therapies are tolerated and assesses the treatment results over the same period. Participants diagnosed with LV will provide information through medical records and clinical data. Researchers will evaluate diagnostic test accuracy, treatment tolerability, and therapeutic outcomes. The study collects this information to better understand the disease's behavior in the region and improve management strategies. Participation involves no direct intervention, and data collection spans five years, ending in December 2025.
CONDITIONS
Brief Title
Visceral Leishmaniasis in Emilia-Romagna (Leishmania-2019)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of any age with microbiologically established diagnosis of visceral Leishmaniasis
- Obtaining Informed Consent
You will not qualify if you...
- Not having obtained Informed Consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to several weeks depending on test scheduling
Participants undergo diagnostic tests including serological and molecular biology tests to confirm visceral leishmaniasis.
1 to 2 visits depending on diagnostic procedures
Duration - Up to 5 years (March 2020 - February 2025)
Participants are observed over time to monitor epidemiology, clinical characteristics, therapy tolerability, and therapeutic outcomes of visceral leishmaniasis.
Periodic visits as per clinical management
Trial Site Locations
Total: 5 locations
1
Ospedale M. Bufalini di Cesena, AUSL della Romagna
Cesena, Forlì-Cesena, Italy, 47521
Actively Recruiting
2
Ospedale G.B. Morgagni L. Pierantoni di Forlì
Forlì, Forlì-Cesena, Italy, 47121
Actively Recruiting
3
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
4
Ospedale S. Maria delle Croci di Ravenna, AUSL della Romagna
Ravenna, Italy, 48121
Actively Recruiting
5
Ospedale Infermi di Rimini, AUSL della Romagna
Rimini, Italy, 47923
Actively Recruiting
Research Team
P
Pierluigi Viale, MD
S
Silvia Cretella, BSc; MBio
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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