Clinical Prognostic Score to Predict Relapse in VL
ConditionVisceral Leishmaniasis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorInstitute of Tropical Medicine, Belgium
About this trial
This prospective cohort study has the aim to develop a prognostic tool to predict relapse in patients suffering from visceral leishmaniasis (VL) from VL endemic regions in Ethiopia.
Therefore, comprehensive clinical and laboratory characterization of all confirmed VL patients before and during treatment will be performed in order to identify the factors that determine prognosis of the patients. This approach would result in more efficient patient care and would reduce the case fatality and morbidity, and improve follow-up and care for those at risk of VL relapse.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
clinically or parasitologically confirmed VL
Disqualifiers
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
Trial population
Patients with clinically or parasitologically confirmed VL in Northern Ethiopia
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
741 Participants
are divided into 1 treatment groupGroup A: VL patients1 intervention
Trial outcomes
Primary outcomes
1
Identification of risk factors for relapse
The association between development of relapse and potential risk factors (demographic/clinical characteristics as well as host immunity/Leishmania infection markers)
Time frame
December 20262
Prognostic tool for relapse
A clinical decision algorithm, prioritizing and integrating identified risk factors, that is able to most efficiently predict the risk of developing relapse within 12 months after start of treatment
Time frame
December 2026Secondary outcomes
1
Patterns in host immune markers for VL relapse, treatment failure and death
The association between the risk of VL relapse/ treatment failure/ death and the levels and evolution of the different host immune markers.
Time frame
December 20262
Identification of risk factors for treatment failure
The association between the occurence of treatment failure and potential risk factors (demographic/clinical characteristics as well as host immunity/Leishmania infection markers)
Time frame
December 20263
Identification of risk factors for death
The association between occurrence of death and potential risk factors (demographic/clinical characteristics as well as host immunity/Leishmania infection markers)
Time frame
December 2026Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Tropical Medicine, Belgium
Lead sponsor
University of Gondar
Collaborator
Source ClinicalTrials.gov