Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06118749
Study type Observational
Source Foundation for Innovative New Diagnostics, Switzerland
Contact Dawn Maranga
Phone +254722554641
Email Dawn.Maranga@finddx.org
Status Not yet recruiting
Phase
Start date November 20, 2023
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Terminated NCT02839603 - Asymptomatic Leishmania Infection in HIV Patients
Completed NCT00370825 - Combination Chemotherapy for the Treatment of Indian Kala-Azar Phase 2
Recruiting NCT05426577 - Evaluation of Less Invasive Procedures for Visceral Leishmaniasis Treatment Efficacy Monitoring Test of Cure
Completed NCT01069198 - A Community Trial for Visceral Leishmaniasis (VL) N/A
Completed NCT00604955 - Expand Access/Assess Safety and Efficacy of Paromomycin IM Injection for the Treatment of Visceral Leishmaniasis Phase 4
Completed NCT00371995 - Short Course of Miltefosine and Liposomal Amphotericin B for Kala-azar Phase 2
Completed NCT01032187 - Amphotericin B to Treat Visceral Leishmaniasis in Brazilian Children Phase 4
Completed NCT00342823 - Immunogenetics of Visceral Leishmaniasis N/A
Completed NCT04003532 - LAMP Assay for the Diagnosis of Visceral Leishmaniasis
Terminated NCT01980199 - Trial to Determine Efficacy of Fexinidazole in Visceral Leihmaniasis Patients in Sudan Phase 2
Completed NCT00255567 - Efficacy/Safety of Sodium Stibogluconate (SSG) Versus Paromomycin (PM) and SSG/PM Combination to Treat V Leishmaniasis Phase 3
Recruiting NCT04342715 - A Study to Assess Immune Response Status in Patients Before and After Treatment for Visceral Leishmaniasis
Completed NCT02431143 - Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa Phase 2
Completed NCT01122771 - Phase III, Study of Three Short Course Combo (Ambisome®, Miltefosine, Paromomycin) Compared With AmBisome for the Treatment of VL in Bangladesh Phase 3
Completed NCT03636659 - Steady State Global Bioequivalence Study of Amphotericin B Liposome for Injection 50 mg/ Vial in Fed Condition Phase 1
Not yet recruiting NCT01566552 - Single Dose Liposomal Amphotericin B for Visceral Leishmaniasis Phase 4
Completed NCT00696969 - Safety and Efficacy Study to Evaluate Different Combination Treatment Regimens for Visceral Leishmaniasis Phase 3
Completed NCT00318721 - Efficacy, Acceptability and Cost-effectiveness of Long Lasting Insecticide Nets (LLIN) in the Prevention of Kala Azar N/A
Completed NCT00216346 - Safety and Efficacy Study of Paromomycin to Treat Visceral Leishmaniasis Phase 3
Completed NCT02011958 - Efficacy Trial of Ambisome Given Alone and Ambisome Given in Combination With Miltefosine for the Treatment of VL HIV Positive Ethiopian Patients. Phase 3