Gondar

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.

Tuberculosis TB remains a major global health challenge, with many cases going undetected and untreated, particularly in low-resource settings such as Guinea-Bissau and Ethiopia. This trial evaluates whether improving current point-of-care diagnostic methods can increase TB case detection rates and enable earlier treatment, potentially reducing transmission and improving outcomes. The study compares an Enhanced Usual Diagnostic Procedure EUDP with an Optimized Diagnostic Procedure ODP that incorporates novel strategies like computer-aided detection CAD of chest X-rays and non-sputum sample testing. The study uses a stepped-wedge cluster-randomized design, where participating health centers start with the standard diagnostic approach EUDP and later switch to the intervention ODP. The ODP includes oral and mobile phone-guided sputum sampling instructions, pooling of sputum samples for improved microscopy and molecular testing, and additional non-sputum sample collection buccaltongue swabs, saliva, and fecal samples analyzed by GeneXpert Ultra PCR. Smear-negative patients undergo chest X-ray evaluation with CAD software to identify active TB cases. Participants presenting with TB symptoms such as cough, sputum production, or weight loss will be assessed using the Bandim TBscore to determine diagnostic referral. Follow-up visits will occur one week after initial evaluation to ensure treatment initiation or reassessment. Researchers will measure diagnostic yields comparing EUDP and ODP over 1.5 years, tracking smear, PCR, and chest X-ray positivity, treatment numbers, and follow-up rates. The study also evaluates the feasibility of advanced sequencing techniques for resistance detection and supports capacity building in the participating countries.

Researchers are investigating the causes and factors that lead to relapse and parasite persistence in patients with visceral leishmaniasis VL who also have HIV infection in Ethiopia. The study aims to better understand how these infections interact, particularly focusing on why some patients experience chronic or recurrent disease despite treatment. This observational cohort study includes both new and retrospective patient data to analyze clinical, laboratory, and molecular findings. Participants will be observed over time without receiving experimental treatments. The study will monitor parasite levels in blood and tissue samples before, during, and after treatment, and during follow-up. Researchers will also examine HIV co-infection characteristics, potential drug resistance, parasite genetics, and other latent infections like tuberculosis and malaria. Quality of life assessments and exploratory studies on skin parasite persistence and stool microbiome will also be conducted. Participants will undergo routine clinical and laboratory evaluations, molecular diagnostic tests, and standardized questionnaires to assess quality of life. The main outcome is identifying host and pathogen factors linked to active chronic infection over 12 months. Participants are expected to attend follow-up visits to support monitoring and data collection. The study will run until December 2027 and does not involve interventional treatments.