Visceral Leishmaniasis in Emilia-Romagna (Leishmania-2019)

NCT06793111 | Recruiting

• 1 other identifier: Leishmania-2019
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Leishmaniasis, Visceral

Keywords

Leishmaniasis

Outcome Measures

Primary Outcomes (2)

• Epidemiology of Visceral Leishmaniasis (VL) cases in Emilia-Romagna

  In-depth description of the epidemiology of autochthonous visceral Leishmaniasis in the Emilia-Romagna region, focusing on the increase in diagnosed cases since 2012. The study will provide critical data for identifying trends in incidence, affected populations, and geographical hotspots, essential for guiding public health interventions. Measure: Number of diagnosed cases per year across participating centers. Unit of measure: Number of cases (n). Collection method: Review of medical records and epidemiological registries.

  March 2020 - February 2025

• Socio-demographic and clinical characteristics of patients diagnosed with VL

  Detailed analysis of the clinical features and presentations of diagnosed LV cases, including common symptoms such as fever, weight loss, splenomegaly, and laboratory findings like anemia and pancytopenia. This analysis will help establish a clearer clinical profile for early diagnosis and treatment strategies. Measure: Age, gender, comorbidities, geographic area of residence, known exposure mode. Unit of measure: Mean ± standard deviation (continuous variables), percentages (categorical variables). Collection method: clinical data collection.

  March 2020 - February 2025

Secondary Outcomes (3)

• Diagnostic accuracy of methods used for VL identification

  March 2020 - February 2025

• Monitoring of therapy tolerability

  March 2020 - February 2025

• Evaluation of therapeutic outcomes of treated cases.

  March 2020 - February 2025

Eligibility Criteria

• Age: 6 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any patient with a diagnosis of established Visceral Leishmaniasis but also patients with a diagnosis of prior Visceral Leishmaniasis.

You may qualify if:

• Patients of any age with microbiologically established diagnosis of LV.
• Obtaining Informed Consent.

You may not qualify if:

• not having obtained Informed Consent

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• AUSL Romagna Rimini: collaborator
• Ospedale Bufalini di Cesena, Italy: collaborator
• Morgagni Pierantoni Hospital: collaborator
• Ospedale "Santa Maria delle Croci" di Ravenna - AUSL Romagna: collaborator

Study Sites (5)

Ospedale M. Bufalini di Cesena, AUSL della Romagna

Cesena, Forlì-Cesena, 47521, Italy

RECRUITING

Ospedale G.B. Morgagni L. Pierantoni di Forlì

Forlì, Forlì-Cesena, 47121, Italy

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

Ospedale S. Maria delle Croci di Ravenna, AUSL della Romagna

Ravenna, 48121, Italy

RECRUITING

Ospedale Infermi di Rimini, AUSL della Romagna

Rimini, 47923, Italy

RECRUITING

MeSH Terms

Conditions

Leishmaniasis, Visceral; Leishmaniasis

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pierluigi Viale, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierluigi Viale, MD

CONTACT

+390512143353; pierluigi.viale@unibo.it

Silvia Cretella, BSc; MBio

CONTACT

+390512143353; silvia.cretella@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 27, 2025
• Study Start: April 21, 2020
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)