Prognostic tool to predict relapse in visceral leishmaniasis patients
Comprehensive Clinical and Laboratory Assessment of Visceral Leishmaniasis to Develop Clinical Prognostic Tools to Predict Relapse: a Prospective Cohort Study in Ethiopia
This study is trying to create a tool to help doctors predict which patients with visceral leishmaniasis in Ethiopia are at risk of relapse after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 741 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Institute of Tropical Medicine, Belgium Academic / other |
| Locations | 1 site (Gonder) |
| Trial ID | NCT05602610 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a prognostic score to predict relapse in patients suffering from visceral leishmaniasis (VL) in Ethiopia. By conducting a comprehensive clinical and laboratory characterization of confirmed VL patients before and during treatment, the study seeks to identify key factors that influence patient prognosis. Understanding these factors will enable healthcare providers to stratify patients based on their risk of relapse, allowing for tailored monitoring and treatment strategies. The ultimate goal is to improve patient outcomes and reduce morbidity and mortality associated with VL.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 12 years and older with clinically or parasitologically confirmed visceral leishmaniasis.
Not a fit: Patients who are critically ill, already on treatment for more than three days, or unlikely to adhere to follow-up visits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient care and outcomes for those at risk of relapse from visceral leishmaniasis.
How similar studies have performed: While the approach of developing prognostic tools for VL is recognized, this specific study's methodology and focus on Ethiopian patients may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinically or parasitologically confirmed VL Exclusion Criteria: * Age under 12 years * VL patients already on treatment for 3 days or more * Severe critical condition or other circumstances that make the study medically inadvisable * Unlikely to adhere to follow up visits during the study period (e.g. patients who live or work very far away) AND not reachable by phone for follow-up information * Pregnant or lactating woman
Where this trial is running
Gonder
- University of Gondar — Gonder, Ethiopia (Recruiting)
Study contacts
- Principal investigator: Eleni Ayele, MD — University of Gondar, Gondar, Ethiopia
- Study coordinator: Saskia van Henten, MD
- Email: svanhenten@itg.be
- Phone: +32(0)32476556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.