Visceral Leishmaniasis in Emilia-Romagna (Leishmania-2019)

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.

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.

Diagnostic accuracy of methods used for VL identification

Evaluation of the diagnostic accuracy of available methods (serological tests, RT-PCR, direct microscopy, and culture) in identifying LV cases, particularly in immunocompromised patients and those with atypical presentations. The study will assess the effectiveness of these tests in different clinical scenarios, including their sensitivity and specificity. Measure: Sensitivity, specificity, positive and negative predictive values of diagnostic tests (EIA, IFAT, RT-PCR, rK39 ICT, direct microscopy). Unit of measure: Percentage (%). Collection method: Comparison with the diagnostic gold standard (bone marrow biopsy with parasite identification).

Monitoring of therapy tolerability

Ongoing assessment of the safety and tolerability of therapeutic interventions used to treat LV, with a focus on identifying potential adverse effects or complications arising from current treatment regimens. This includes monitoring for any therapy-related side effects and evaluating the suitability of treatment options in different patient populations. Measure: Number of participants with adverse events (evaluated according to CTCAE v4.0 criteria). Unit of measure: Number of adverse events (n), percentage (%). Collection method: Adverse event reporting forms and clinical reports.

Evaluation of therapeutic outcomes of treated cases.

Comprehensive assessment of the therapeutic outcomes in patients treated for LV, measuring the effectiveness of current treatment protocols in terms of clinical improvement, survival rates, and relapse prevention. This will also involve tracking long-term patient recovery and any subsequent need for retreatment. Measure: Complete cure rate, recurrence rate at 6 and 12 months, disease-related mortality. Unit of measure: Percentage (%), time to recurrence in days (d). Collection method: Clinical and laboratory follow-up.