Comprehensive Clinical and Laboratory Assessment of Visceral Leishmaniasis to Develop Clinical Prognostic Tools to Predict Relapse: a Prospective Cohort Study in Ethiopia

What this Trial Is About

Researchers are conducting a prospective cohort study to develop a tool that predicts relapse in patients with visceral leishmaniasis (VL) from endemic regions in Ethiopia. The study aims to identify factors that influence prognosis by thoroughly assessing clinical and laboratory data before and during treatment. This effort seeks to improve patient care, reduce death and illness rates, and enhance monitoring for those at risk of VL relapse. The study involves comprehensive clinical and laboratory evaluations of confirmed VL patients. These assessments include a wide range of parameters such as immune markers, blood tests including coagulation profiles and cultures, and clinical conditions like sepsis and comorbidities. The goal is to create prognostic tools of varying complexities suited to different healthcare settings, which will help stratify patients into high and low risk groups for relapse, treatment failure, and mortality. Participants will undergo detailed follow-up throughout treatment to collect data that helps identify risk factors for relapse, treatment failure, and death. The main outcomes measured include the development of the prognostic tool and identification of key risk factors by December 2026. This observational study monitors patients without any intervention, focusing on improving understanding and management of VL through ongoing clinical and laboratory evaluations.

Clinical Prognostic Score to Predict Relapse in VL