Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring T… (NCT05426577) | Clinical Trial Compass
UnknownNot Applicable
Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure
Ethiopia60 participantsStarted 2021-09-01
Plain-language summary
Left untreated, visceral leishmaniasis (VL) is fatal. The highest burden of VL worldwide is in eastern Africa where field-adapted diagnostic and test-of-cure tools and treatment are lacking. The current laboratory tool to help assessing cure, treatment failure and relapse is microscopy, based on invasive sampling (e.g. splenic or bone marrow aspirate). Non-invasive, more sensitive tools will enable these assessments with minimum risk and discomfort to patients.
This study aims to evaluate immunological and molecular tests to predict cure and relapse, and to replace with these the current invasive methods.
The study will be conducted at the Leishmaniasis Research and Treatment Centre (LRTC), Gondar University Hospital, Ethiopia It will be a non-intervention study, the tools under evaluation will be considered as index tests; their results will not influence patient management during the duration of the study. Patient management will follow the national guidelines for VL diagnosis and management in Ethiopia.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with clinical signs and symptoms of VL and confirmatory parasitological microscopic diagnosis.
* Patients for whom written informed consent has been obtained (if aged 18 years and over) or signed by parents(s) or legal guardian for patients under 18 years of age (in the case of minors, assent from the children also needs to be obtained as per country regulatory requirements).
Exclusion Criteria:
VL cases will not be enrolled in the study if any of the following exclusion criteria apply:
* Patients who are cases of VL relapse, post- or para-kala-azar dermal leishmaniasis or who have received any anti-leishmanial drugs within the last six months.
* Patients not eligible for treatment with SSG+PM:
* Patients with severe malnutrition.
* Patients with positive HIV diagnosis.
* Patients with previous history of hypersensitivity reaction or known drug class allergy to any of the study treatments (SSG or PM).
* Patients with previous history of cardiac arrhythmia or with a clinically significant abnormal ECG.
* Patients suffering from a concomitant severe infection such as TB or any other serious underlying disease (cardiac, renal, hepatic), or chronic condition which would preclude evaluation of the patient's response to study medication.
* Patients who cannot comply with the planned procedures and scheduled visits of the study protocol.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the diagnostic performance of the immunological tests under evaluation for predicting cure and treatment failure at end-of-treatment assessment
Timeframe: At 6 month follow up
2
To assess the diagnostic performance of the molecular tests under evaluation for predicting cure and treatment failure at end-of-treatment assessment
Timeframe: At 6 month follow up
Trial details
NCT IDNCT05426577
SponsorFoundation for Innovative New Diagnostics, Switzerland