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Visceral Leishmaniasis clinical trials

View clinical trials related to Visceral Leishmaniasis.

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NCT ID: NCT06118749 Not yet recruiting - Clinical trials for Visceral Leishmaniasis

Leishmania Antigen Rapid Diagnostic Test Proof-of-Concept and Validation Study

Start date: November 20, 2023
Phase:
Study type: Observational

Visceral leishmaniasis (VL) or kala azar is a neglected tropical disease(NTD) caused by protozoan parasites of the Leishmania donovani complex that are transmitted by phlebotomine sand flies. An estimated 50,000 - 90,000 new cases occur worldwide annually. It is characterized by fever, weight loss, enlargement of the spleen and liver, and anaemia, and it can be fatal in more than 95% of cases without treatment. The Horn of Africa accounts for the largest number of VL cases worldwide, and communities living in remote, resource-limited settings are at greatest risk of infection. Therefore, early and accurate diagnosis of VL in health facilities is essential. VL is fatal if it is not adequately treated. The drugs currently used to treat VL can have severe side effects and the clinical presentation of VL is not sufficiently specific to guide treatment. Highly accurate (both sensitive and specific), cheap and simple rapid diagnostic tests (RDTs) are therefore crucial for case-management of VL. Early case detection followed by adequate treatment is also central to control of VL. In Kenya, Visceral leishmaniasis is diagnosed by the rK39 RDT based on detection of host antibody to a 39-aminoacid-repeat recombinant leishmanial antigen in clinically suspected cases. Because this test has a suboptimal sensitivity of around 85%, other additional diagnostic tests are often necessary. These include the direct agglutination test (DAT) based on agglutination of whole parasite antigen by parasite specific host antibodies and microscopy detection of amastigotes in stained smears from lymph node punctures, bone marrow or spleen aspirates currently the gold standard for confirmatory diagnosis. While the use of rK39 RDT and DAT has been on the increase, the tests cannot distinguish active from past infections as they are based on detection of antileishmania antibodies which are present in both active and past infections. Furthermore, DAT requires some laboratory skills and overnight incubations before obtaining the results and the rK39 has low sensitivity when used in Eastern Africa. There have therefore been efforts to develop an antigen detection based test that is based on minimally invasive specimen collection such as blood or urine. To this end, a collaboration between KEMRI, DNDi, FIND and the University of York under the Next generation diagnostics and oral treatment for visceral leishmaniasis in Eastern Africa: transforming patient care through innovation (VL-INNO) EDCTP project, aims to develop an antigen based diagnostic test based on parasite biomarkers in urine and blood from VL patients. In this project, a proteomics approach will be used to identify candidate Leishmania antigens that are found in the blood and urine of confirmed visceral leishmaniasis. The University of York will undertake proteomics analyses of the specimens using highly sensitive Liquid Chromatograph Triple Quadrupole Mass Spectrometer (LCMS/MS) to explore antigen diversity in defined archived clinical samples (blood, urine) from VL patients before and after treatment. Based on yield, stability and immunogenicity of the antigens, monoclonal antibodies (mAb) will be production for subsequent development of a lateral flow rapid diagnostic test(RDT) prototype that can detect leishmania antigens in blood and/or urine of VL patients. With these activities initiated using samples previously collected from VL patients in Kenya, this current protocol seeks to collect samples (blood and urine) from two VL treatment centres namely Chemolingot Sub-county hospital in Baringo County and Kacheliba Sub-county, West Pokot, to be used in the evaluation of the RDT prototype. We will analyze samples from VL patients collected before and at the end of treatment, to determine the sensitivity of the test and how parasite antigen abundance in urine and blood changes as a consequence of clinical cure. Samples from healthy endemic controls will be used to determine the specificity of the test.

NCT ID: NCT05602610 Recruiting - Clinical trials for Visceral Leishmaniasis

Clinical Prognostic Score to Predict Relapse in VL

CPS
Start date: February 3, 2023
Phase:
Study type: Observational

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.

NCT ID: NCT05426577 Recruiting - Clinical trials for Visceral Leishmaniasis

Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure

VL-ToC
Start date: September 1, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT05386875 Recruiting - Clinical trials for Visceral Leishmaniasis

Evaluation to Assess the Usability of rK28 for the Diagnosis of Visceral Leishmaniasis in Kenya

rK28-AccDemo
Start date: December 31, 2022
Phase:
Study type: Observational

Visceral leishmaniasis (VL) is a fatal disease caused by Leishmania parasites and transmitted by female phlebotomine sandflies. The disease is a serious public health problem in eastern Africa; including Kenya where an estimated 4000 cases occur annually and 5 million people are at risk of infection. Accurate diagnosis of VL is critical for appropriate treatment. Currently, VL diagnosis in Kenya is based on testing suspected patients with the IT-Leish rK39 rapid diagnostic test (RDT) followed by other tests such as the Direct Agglutination Tests (DAT) and microscopy of tissue aspirates (splenic, bone marrow, lymph node) on rK39-negative patients. However, these diagnostic tools present several challenges including; the need for expertise, equipment and low diagnostic sensitivity of (85%) for DAT and rK39. Alternative VL diagnostic tools that are readily available, easy to use with increased sensitivity are needed to improve VL surveillance and control in Kenya. In the present study, we will assess rK28 as a diagnostic tool including performance with increased sensitivity when used together with IT-Leish rK39 and its potential for inclusion in VL diagnosis algorithms and evaluate Kala-azar Detect rK39 for potential use in Kenya. Suspected patients presenting at VL testing facilities in Marsabit, Turkana and Wajir Counties will be recruited prospectively and tested using IT-Leish rK39 followed by DAT for case confirmation according to the national guidelines. Alongside the case confirmation, samples from participants will also be tested using the rK28 and Kala-azar Detect rK39 in whole blood and serum. The collected data will be analyzed and compared separately between the RDTs as well as in combination, and the performance of the algorithms determined retrospectively. This design will enable the assessment of the sensitivity of combining rK28 and rK39 (Kala-azar Detect) compared to rK39 (IT-Leish/Kala-azar Detect) alone. Microscopy will be used as confirmatory test. We will also assess the feasibility, usefulness, and cost-effectiveness of rK28 in the VL diagnostic algorithm, through sensitivity analyses. The improved understanding of rK28 as a VL diagnostic tool and its potential for inclusion in the VL diagnosis algorithm could enable faster and more effective management of cases and accelerate elimination of VL.

NCT ID: NCT04342715 Recruiting - Clinical trials for Visceral Leishmaniasis

A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis

Start date: May 22, 2022
Phase:
Study type: Observational

ImmStat@Cure is a multicentre observational study designed to assess the immune status of patients before and after treatment for visceral leishmaniasis. Forty patients and 30 controls will be recruited per site. The follow-up period is 6 months from the end of treatment.

NCT ID: NCT04003532 Completed - Clinical trials for Visceral Leishmaniasis

LAMP Assay for the Diagnosis of Visceral Leishmaniasis

EvaLAMP
Start date: October 1, 2018
Phase:
Study type: Observational

This study will evaluate the of the loop-mediated amplification assay (LAMP) as a diagnostic as well as a Test-of-Cure (ToC) for visceral leishmaniasis (VL) in an endemic area in Ethiopia. Furthermore, we aim to further development of the direct-blood PCR-Nucleic Acid Lateral-Flow Immuno-Assay (dB-PCR-NALFIA) as a novel diagnostic tool for VL and its subsequent evaluation in the field.

NCT ID: NCT03929016 Completed - Clinical trials for Visceral Leishmaniasis

Single Oral Dose Escalation Study of DNDI-0690 in Healthy Subjects

Start date: April 4, 2019
Phase: Phase 1
Study type: Interventional

This study will evaluate how the test medicine DNDI-0690 is taken up and broken down by the body and will also look at the safety and tolerability of the test medicine after a single dose. This is the first time the test medicine DNDI-0690 will be administered to humans.

NCT ID: NCT03636659 Completed - Clinical trials for Visceral Leishmaniasis

Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition

Start date: May 2, 2018
Phase: Phase 1
Study type: Interventional

The primary objective is to determine clinical bioequivalence of Amphotericin B liposome for injection of Auromedics Pharma LLC, USA and AmBisome (Amphotericin B) liposome for injection of Astellas Pharma US, Inc., in patients with Visceral Leishmaniasis under fed condition

NCT ID: NCT03269006 Completed - Clinical trials for Visceral Leishmaniasis

Improved Case Detection and Vector Control for Visceral Leishmaniasis

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

Visceral leishmaniasis (VL) also known as kala-azar is a public health problem in Bangladesh. Since 2005 a national kala-azar elimination program is going on in the country. The program has preparatory, attack, consolidation and maintenance phases. The target of the program is to reduce the VL incidence less than 1 per 10,000 people at upazila (sub-district) level in VL endemic upazilas of the country. The program is heading successfully to its consolidation phase. During attack phase house to house search for VL suspects and also suspects with Post-kala-azar Dermal Leishmaniasis (PKDL) was the tool for early diagnosis of VL and PKDL cases. Indoor residual spraying with insecticide (Deltamethrin) was the method for sand fly control to reduce the transmission of the disease. Since in the consolidation phase the VL case load is many times less than that in the attack phase, house to house search for VL and PKDL cases and IRS for vector control is no more cost-effective for the program. Therefore there is a need for alternative methods for active search of VL and PKDL cases and method for sand fly control, appropriate for the consolidation phase. In the present study the investigators propose to investigate the efficacy of Inesfly 5AIGRNG TM containing Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%), commercial available durable wall lining (DWL), impregnated of existing bed-net with insecticide tablet, KO TAB 123, indoor residual spraying (IRS) with Delthamethrin against a control group Methods: A cluster randomized controlled design to measure sand fly density reduction at intervention household as well as sand fly mortality by entomological methods. Outcome measures/variables: reduction of sand fly density at intervention household and sand fly corrected mortality on intervention surfaces compare to control households/conditions.

NCT ID: NCT03129646 Completed - Clinical trials for Visceral Leishmaniasis

Miltefosine/Paromomycin Phase III Trial for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa

Start date: January 24, 2018
Phase: Phase 3
Study type: Interventional

This is an open label, Phase III, randomized, controlled, parallel arm multicentre non-inferiority clinical trial to compare the efficacy and safety of two combination regimens of Miltefosine and Paromomycin with the standard SSG-PM for the treatment of primary adult and children VL patients in Eastern Africa.