Visceral LeishmaniasisCPSNCT05602610
Clinical Prognostic Score to Predict Relapse in VL
An observational study of Visceral Leishmaniasis, run by Institute of Tropical Medicine, Belgium at 1 site in Ethiopia.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Visceral Leishmaniasis
- How many people
- 741 participants
- Where
- 1 siteEthiopia
- Study dates
- 3 Feb 2023to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with clinically or parasitologically confirmed VL in Northern Ethiopia
Who may be able to join
- clinically or parasitologically confirmed VL
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia1 site, 1 recruiting
- Recruiting
University of Gondar
Gonder
Eleni Ayele
About this study
Official title: Comprehensive Clinical and Laboratory Assessment of Visceral Leishmaniasis to Develop Clinical Prognostic Tools to Predict Relapse: a Prospective Cohort Study in Ethiopia
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.
Read the 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.
- Conditions
- Visceral Leishmaniasis
- Being tested
- No intervention
- Keywords
- leishmaniasis, visceral, neglected, relapse, Ethiopia
- Medical subject headings
- Leishmaniasis, Visceral, Leishmaniasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| VL patients | VL infected individuals residing in/ with travel history to VL-endemic areas in Northern Ethiopia Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: December 2026
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
Measured: December 2026
Secondary outcomes (3)
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.
Measured: December 2026
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)
Measured: December 2026
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)
Measured: December 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start3 Feb 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral LeishmaniasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 741 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- University of Gondar
- Responsible party
- Sponsor
- Investigators
- Saskia van Henten, MD, Study chair, Institute of Tropical Medicine Antwerp, Antwerp, BelgiumEleni Ayele, MD, Principal investigator, University of Gondar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602610
- Sponsor's protocol ID
- 1544/21
- Acronym
- CPS
- Status last verified
- Mar 2024
- First submitted
- 27 Oct 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Raw data may be made available through a controlled access procedures (privacy restrictions)
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Clinical and Laboratory Assessment of Visceral Leishmaniasis to Develop Clinical Prognostic Tools to Predict Relapse: a Prospective Cohort Study in Ethiopia
- ClinicalTrials.gov ID
- NCT05602610
- Acronym / sponsor ID
- CPS / 1544/21
- Conditions
- Visceral Leishmaniasis
- Keywords
- leishmaniasis, visceral, neglected, relapse, Ethiopia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 741 participants (estimated)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- University of Gondar
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VL patients | – | Other: No interventionVL infected individuals residing in/ with travel history to VL-endemic areas in Northern Ethiopia |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with clinically or parasitologically confirmed VL in Northern Ethiopia
Key inclusion criteria (1 listed)
- clinically or parasitologically confirmed VL
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | VL patients |
Primary outcome
Identification of risk factors for relapse
Time frame: December 2026
The association between development of relapse and potential risk factors (demographic/clinical characteristics as well as host immunity/Leishmania infection markers)
Prognostic tool for relapse
Time frame: December 2026
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
3 secondary outcomes
Patterns in host immune markers for VL relapse, treatment failure and death
Time frame: December 2026
Identification of risk factors for treatment failure
Time frame: December 2026
Identification of risk factors for death
Time frame: December 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: Undecided. Raw data may be made available through a controlled access procedures (privacy restrictions)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saskia van Henten, MD study chair
Institute of Tropical Medicine Antwerp, Antwerp, Belgium
Eleni Ayele, MD principal investigator
University of Gondar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visceral Leishmaniasis, run by Institute of Tropical Medicine, Belgium at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saskia van Henten, MD (+32(0)32476556, svanhenten@itg.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of risk factors for relapse (time frame: December 2026). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.