Project: Towards an adapted, safe, effective combination treatment for African visceral leishmaniasis (Kala Azar) and improved diagnostic tools.

Acronym Afri-KA-DIA (Reference Number: RIA2016S-1635)
Duration 01/12/2017 - 30/11/2020
Project Topic Visceral leishmaniasis, also called kala-azar, is a neglected tropical disease spread by the bite of an infected female sand-fly. There are between 50,000 and 90,000 new cases of visceral leishmaniasis every year worldwide. Fatal if left untreated, currently the highest burden of the disease is in eastern Africa (Ethiopia, Kenya, Somalia, South Sudan, Sudan, and Uganda) where most people affected live in remote areas far from health facilities. More than 50% of those affected are children. Current treatments for visceral leishmaniasis are toxic and painful and require hospitalization and daily injections. There is an urgent need for improved treatments that are safe, effective, more patient-friendly and appropriate for use in remote areas that do not have well-equipped health facilities. Through the coordination of DNDi, the Afri-KA-DIA consortium is leading a project which addresses the main pillars of the disease : treatment, diagnostics and capacity building.  The projects’ core mandate is to carry out a Phase III clinical trial to evaluate the efficacy and safety of a combination of oral miltefosine (MF) and paromomycin (PM) in treating visceral leishmaniasis in eastern Africa, compared to the standard 17-day treatment of Sodium Stibogluconate (SSG)&PM combination. The clinical trial will run hand-in-hand with an assessment of innovative,  less invasive diagnostic tools for detection and management of visceral leishmaniasis patients. Currently  there are no reliable, easy-to-use, highly sensitive diagnostic tests that can detect the disease and confirm when patients have been cured. Countries in the region, still use invasive and risky procedures such as splenic or bone marrow aspirate for diagnosis. Launched in December 2017, Afri-KA-DIA started recruiting patients in the clinical trial and carried out important capacity building activities.  The first year of Afri-KA-DIA consisted of implementing the clinical trial in Kenya, Sudan, Uganda and Ethiopia. Preparatory work for the trials included procurement of drugs and supplies, laboratory upgrade, development of operation manuals and standard operating procedures, study forms, a data management plan, statistical analysis plan and  case report forms. Training were conducted at the participating sites for trial personnel and first patient was enrolled in the trial in January 2018. In order to address current gaps in VL diagnosis in eastern Africa, a large-scale diagnostic study is under preparation to guide country-specific policies with regard to the inclusion of the best performing rapid diagnostic test (RDT) for VL management. Strengthening research capacity is an integral part of Afri-KA-DIA. Through training courses, workshops, quality control and quality assurance programmes, young researchers will learn to conduct clinical trials according to approved international and local standards, gaining valuable experience in the process. Trainings were held in areas such as Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) for site personnel involved in the project as well as Good Financial Practice (GFP) for the finance and administrative staff in eastern African partner’s institutions. The project has been presented in several key events including the 15th LEAP (Leishmaniasis East Africa Platform) conference. Access to information regarding Afri-KA-DIA has been developed through the creation of a public website to allow for a updates on news and events as well as a description of the disease and the project itself;  https://www.afrikadia.org/.
Network EDCTP2
Call Strategic actions supporting large-scale clinical trials 2016

Project partner

Number Name Role Country
1 Drugs for Neglected Diseases initiative Coordinator Switzerland
3 Academisch Medisch Centrum bij de Universiteit van Amsterdam Partner Netherlands
5 Foundation for Innovative New Diagnostics Partner Switzerland
7 Instituto de Salud Carlos III Partner Spain
9 Kenya Medical Research Institute Partner Kenya
11 London School of Hygiene and Tropical Medicine Partner United Kingdom
13 Makerere University Partner Uganda
15 Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek ziekenhuis Partner Netherlands
17 University of Gondar Partner Ethiopia
19 University of Khartoum Partner Sudan