Actively Recruiting

Age: 6Years - 90Years
All Genders
ID06793111

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

Age: 6Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of any age with microbiologically established diagnosis of visceral Leishmaniasis
  • Obtaining Informed Consent
Not Eligible

You will not qualify if you...

  • Not having obtained Informed Consent

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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