Clinical trial NCT05602610: Clinical Prognostic Score to Predict Relapse in VL
Official title: Comprehensive Clinical and Laboratory Assessment of Visceral Leishmaniasis to Develop Clinical Prognostic Tools to Predict Relapse: a Prospective Cohort Study in Ethiopia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Visceral Leishmaniasis
Keywords: leishmaniasis
visceral
neglected
relapse
Ethiopia
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: University of Gondar
First posted: 2022-11-02
Enrollment: 741
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with clinically or parasitologically confirmed VL in Northern Ethiopia

Brief summary: 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.

Detailed description: Certain patient groups seem to be at higher risk of poor outcomes. Although the average case fatality rate was \<10% in Ethiopia , certain subgroups of VL patients are at significantly higher risk of dying, with case fatality rates as high as 39% when patients coinfected with HIV or sepsis. The host's immunocompetence appears to play a critical factor associated with disease development, severity, treatment success and disease relapse. Yet, a substantial group of immunocompetent patients also fail to respond well to treatment, or develop relapse after cure. Relapse is increasingly recognized as an important clinical challenge, with 10-15% estimated to develop relapse in the Ethiopian setting. Understanding which factors determine prognosis among VL patients is key in improving outcomes, as high-risk patients can be identified and receive additional monitoring, care, investigations or preferential treatment with safer or more effective drugs.

One of the strategies to improve patient outcome is identification of factors that determine the prognosis of a patient. These factors can be used in clinical decision tools to provide the most appropriate care for each patient. With the key prognostic factors, patients can be stratified in high and low risk of relapse, treatment failure and mortality and can be treated accordingly, providing intensive monitoring and/or treatment of comorbidities of high-risk patients and a more decentralized follow-up for low-risk 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.

No clinical tools for prediction of relapse and treatment failure currently exist. The existing clinical tools for predicting mortality developed so far have a fair accuracy but these tools could further be improved by using prognostic markers both before and during treatment and including more relevant parameters which were previously ignored, such as more laboratory parameters including coagulation profile, blood culture, immunological markers and more relevant clinical parameters such as sepsis and comorbidities.

This study will perform a comprehensive clinical and laboratory characterization of all confirmed VL patients before and during treatment with the main objective to develop a prognostic tool for unfavorable outcome among hospitalized patients. It is planned to develop tools of different complexity, geared towards the capacity of the health facility and also study the added effect of each variable in the tool. The data from this study will address a number of outstanding unanswered questions that could help to improve or standardize VL management.

Eligibility 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

Primary outcomes:
measure: Identification of risk factors for relapse
timeFrame: December 2026
measure: Prognostic tool for relapse
timeFrame: December 2026
Secondary outcomes:
measure: Patterns in host immune markers for VL relapse, treatment failure and death
timeFrame: December 2026
measure: Identification of risk factors for treatment failure
timeFrame: December 2026
measure: Identification of risk factors for death
timeFrame: December 2026
Other outcomes:
Locations:
city: Gondar
country: Ethiopia
facility: University of Gondar
Study officials:
affiliation: Institute of Tropical Medicine Antwerp, Antwerp, Belgium
name: Saskia van Henten, MD
role: STUDY_CHAIR
affiliation: University of Gondar, Gondar, Ethiopia
name: Eleni Ayele, MD
role: PRINCIPAL_INVESTIGATOR
References: