Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05602610 |
| Other study ID # |
1544/21 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 3, 2023 |
| Est. completion date |
June 30, 2027 |
Study information
| Verified date |
March 2024 |
| Source |
Institute of Tropical Medicine, Belgium |
| Contact |
Saskia van Henten, MD |
| Phone |
+32(0)32476556 |
| Email |
svanhenten[@]itg.be |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
