Clinical trial Recruiting at 1 site Observational Ages 12 and up

Prognostic tool to predict relapse in visceral leishmaniasis patients

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

Run by Institute of Tropical Medicine, Belgium · NCT05602610 · Data updated 2026-11-12

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.

More Visceral Leishmaniasis trials

Quick facts

Study typeObservational
Ages12 Years and up
SexAll
Enrollment741 (estimated)
SponsorInstitute of Tropical Medicine, Belgium
Academic / other
Locations1 site (Gonder)
StatusRecruiting
StartedFebruary 3, 2023
Main results expectedDecember 31, 2026
Study endsJune 30, 2027
Registry record updatedMarch 5, 2024
Trial IDNCT05602610 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals aged 12 years and older with clinically or parasitologically confirmed visceral leishmaniasis.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • University of Gondar
    Gonder, Ethiopia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.