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 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, whilst patients, especially children, live in poorly accessible areas far from health facilities. A new field-adapted combination treatment will improve safety and reduce pain and cost, while new non-invasive, more sensitive tools for VL diagnosis and monitoring will enable diagnosis in remote resource-limited settings, with minimum risk and discomfort to patients. What Afri-KA-DIA aims to achieve This large-scale Phase III clinical trial aims to deliver a new, efficacious treatment regimen for VL – replacing the current, too toxic and-unfriendly option (sodium stibogluconate and paromomycin – 17 days, double daily injections) with oral miltefosine and paromomycin. In the context of the trial, we propose to demonstrate the usefulness of innovative diagnostic tools and biomarkers for managing VL cases in routine patient care in the field. The drug trial will run across six sites in Kenya, Uganda, Ethiopia and Sudan in 576 patients. The results should directly support policy change in endemic countries and eliminate the need for antimonial-based treatments. Afri-KA-DIA will: • Develop a safe, efficacious, field-adapted new combination therapy for VL in eastern Africa (work package (WP1); • Evaluate pharmacokinetic and pharmacodynamic profiles of the new combination treatment in VL patients (WP1); • Evaluate LAMP and different biomarkers as tests-of-cure and predictors of relapses to replace the current invasive methods (WP2); • Evaluate a new rapid diagnostic test for diagnosis of primary case detection, either in passive or in active case detection (WP2); • Provide scientific evidence supporting policy change and build clinical trial capacity in eastern Africa (WP3). The Afri-KA-DIA consortium Over the last 12 years, the consortium partners have conducted innovative VL clinical trials in this region, many were joint efforts. The consortium comprises: • Three leading universities and one research institution from eastern Africa with proven collaborations with one another, established networks and expertise in this region; • Four leading European research institutions with a strong track record in field-based research; and • Two well-respected not-for-profit product development partnerships specialised in R&D for neglected diseases. The clinical trial will be implemented under the Leishmaniasis East Africa Platform (LEAP), the research and training platform dedicated since its inception to the conduct of trials in leishmaniasis and coordinated by DNDi’s regional office in Kenya. This package of care combining non-invasive treatment and specific diagnosis tool for primary VL could potentially improve overall case management in eastern Africa.
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
2 Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek ziekenhuis Partner Netherlands, The
3 London School of Hygiene and Tropical Medicine Partner United Kingdom
4 Instituto de Salud Carlos III Partner Spain
5 Makerere University Partner Uganda
6 Kenya Medical Research Institute Partner Kenya
7 University of Khartoum Partner Sudan
8 University of Gondar Partner Ethiopia
9 Foundation for Innovative New Diagnostics Partner Switzerland
10 Academisch Medisch Centrum bij de Universiteit van Amsterdam Partner Netherlands, The