Launched in 2018, AfriKADIA is a consortium of ten organizations working to find improved treatments and diagnostic tools for visceral leishmaniasis in eastern Africa.
The AfriKADIA consortium’s main mandate is to conduct a large-scale Phase III clinical trial to assess the efficacy and safety of a combination of oral miltefosine (MF) and paromomycin (PM) in treating visceral leishmaniasis. If found to be efficacious, the introduction of miltefosine in combination with paromomycin will reduce both the difficulty in administering treatment and the length of hospital stays for patients.
Although effective, the current treatment used to treat visceral leishmaniasis in eastern Africa remains sub-optimal as patients can suffer from rare but major side effects, such as cardiotoxicity, hepatotoxicity, and pancreatitis. The treatment is also difficult to administer, since patients must be hospitalized and endure two painful injections every day for 17 days.
The clinical trial is running hand-in-hand with an assessment of innovative, non-invasive diagnostic tools for detection and management of visceral leishmaniasis cases in routine patient care.
The consortium is comprised of: three universities and one research institution from eastern Africa with many years of experience in tropical disease research; four European research institutions with a track record in field-based research; and two not-for-profit product development partnerships specialising in R&D for neglected diseases.
Academisch Medisch Centrum bij de Universiteit van Amsterdam, The Netherlands
Drugs for Neglected Diseases initiative (DNDi), Kenya and Switzerland
FIND, the global alliance for diagnostics, Switzerland
Project information
Developing new improved treatments for visceral leishmaniasis patients in eastern Africa
Eastern Africa currently harbours the highest burden of visceral leishmaniasis worldwide. Despite this burden, existing treatments are still difficult to administer, costly and pose life-threatening toxicities. There is a grave need for a safer, non-antimonial-containing, innovative therapy of short duration that can be deployed more easily, at lower cost, and in remote areas that do not have well-equipped health facilities.
AfriKADIA’s 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 SSG&PM combination. More information on the clinical study: ClinicalTrials.gov
The study is implemented under the Leishmaniasis East Africa Platform (LEAP), the research and training platform dedicated to the conduct of trials in leishmaniasis and coordinated by DNDi’s regional office in Kenya.
Improving visceral leishmaniasis diagnosis by evaluating less invasive tools
Eastern Africa struggles with a lack of patient-friendly, field-adapted diagnostic and test-of-cure tools. Easy-to-use, non-invasive diagnostic tools that can be used in remote settings by health workers with limited training are critical to improving patient care and visceral leishmaniasis control.
To address these diagnostic gaps, AfriKADIA will adopt the infrastructure already established by the Leishmaniasis East Africa Platform (LEAP) to improve visceral leishmaniasis diagnosis and treatment monitoring in eastern Africa by finding a more patient-friendly and field-amenable option.
Building clinical trial capacity and providing scientific evidence to support policy change
Clinical trials on neglected diseases are most often conducted in remote areas with little infrastructure, a lack of trained personnel, and a risk of political instability. Success requires the investment of considerable effort in building capacity at trial sites, including adequate infrastructure and well-trained staff.
Strengthening research capacity is an integral part of AfriKADIA’s mission. Through training courses, workshops, and 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. Although Leishmaniasis East Africa Platform (LEAP) sites have amassed considerable knowledge in clinical research, this project aims to further strengthen the skills of study teams and provide new opportunities for young clinical researchers to gain experience.
The AfriKADIA Consortium is committed to sharing knowledge gained from the project with policy-makers, public health programmes, and key stakeholders. With the evidence gained from the project, LEAP members will use their influence to encourage the adoption of treatment and diagnostic outcomes in eastern Africa.
Coordination of AfriKADIA Project
The AfriKADIA project has established a project management committee (PMC) to coordinate and monitor the project’s progress, and convene biannual engagements with relevant consortium partners.
Project Management Committee members:
- Dr Jorge Alvar, DNDi, Switzerland
- Dr Thomas Dorlo, NKI, Netherlands
- Prof. Michael Miles, LSHTM, UK
- Dr Javier Moreno, ISCIII, Spain
- Dr Joseph Olobo, Makerere University, Uganda
- Dr Jane Mbui, KEMRI, Kenya
- Prof. Ahmed Musa, IEND, Sudan
- Dr Rezika Mohammed, University of Gondar, Ethiopia
- Dr Isra Cruz, FIND, Switzerland
- Dr Henk Schallig, AMC, Netherlands
The PMC is also responsible for the creation of a Project Advisory Committee (PAC) whose role is to annually monitor the quality and progress of the project towards delivering new tools for diagnostics and treatment within the allotted timeframe, as well as ensuring the achievement of planned capacity-building and dissemination goals.
News & resources
- 3 October 2022 - DNDi 2022 Projects of the Year recognize partners and colleagues for their work in developing new treatments for leishmaniasis
- 30 September 2022 - New, combined treatment for VL patients becomes effective in East Africa, Ethiopian Herald
- 30 September 2022 - Hope for kala-azar patients as new treatment is discovered, Nation
- 29 September 2022 - New treatment for visceral leishamaniasis effective – study says, Science Africa
- 29 September 2022 - Better, shorter combination treatment for people with visceral leishmaniasis shown to be effective in Eastern Africa
- 29 September 2022 - The Science Explained: Evaluating an alternative treatment regimen for visceral leishmaniasis in Eastern Africa
- 27 September 2022 - Paromomycin and miltefosine combination as an alternative to treat patients with visceral leishmaniasis in Eastern Africa: A randomized, controlled, multicountry trial, Clinical Infectious Diseases
- 20 June 2022 - My battle and triumph over trickster disease – Kala azar, People Daily
- 10 September 2019 - Sand fly bringing life-threatening kalaazar to semi-arid counties, The East African
- 13 April 2018 - Clinical trial to find new treatment for visceral leishmaniasis begins in eastern Africa
Other resources
- KalaCORE: partnership to support the control and elimination of visceral leishmaniasis in six countries (India, Nepal, Bangladesh, Ethiopia, Sudan, South Sudan)
- WHO’s fact sheet on leishmaniasis
- Neglected tropical diseases course now accessible via eLearning by WHO
Newsletters
Publications
National guidelines for visceral leishmaniasis:
Kenya Ministry of Health’s Strategic Plan for Control of Leishmaniasis (2021-2025)
WHO Technical Report Series on Leishmaniasis, March 2010
Scientific articles
Leishmaniasis immunopathology—impact on design and use of vaccines, diagnostics and drugs by Kaye PM, Cruz I, Picado A, Van Bocxlaer K and Croft SL. Semin Immunopathol 2020, doi: 10.1007/s00281-020-00788-y
Highly sensitive UPLC-MS/MS method for the quantification of paromomycin in human plasma by Roseboom IC, Thijssen B, Rosinga H, Mbui J, Beijnena JH, Dorlo TPC.
Journal of Pharmaceutical and Biomedical Analysis doi.org/10.1016/j.jpba.2020.11324
Urine-based antigen detection assay for diagnosis of visceral leishmaniasis using monoclonal antibodies specific for six protein biomarkers of Leishmania infantum / Leishmania donovani by Abeijon C, Alves F, Monnerat S, Mbui J, Viana AC, Almeida RM, Bueno LL, Fujiwara R, and Campos-Neto A . PLOS Neglected Tropical Diseases 2020, doi.org/10.1371/journal.pntd.0008246
Barriers to access to visceral leishmaniasis diagnosis and care among seasonal mobile workers in Western Tigray, Northern Ethiopia: A qualitative study by Coulborn RM, Gebrehiwot TG, Schneider M, Gerstl S, Adera C, Herrero M, Porten K, den Boer M, Ritmeijer K, Alvar J, Hassen A, Mulugeta A. PLOS Neglected Tropical Diseases 2018, doi: 10.1371/journal.pntd.0006778
Safety, efficacy, and pharmacokinetics of an allometric miltefosine regimen for the treatment of visceral leishmaniasis in Eastern African children: an open-label, phase-II clinical trial by Mbui J, Olobo J, Omollo R, Solomos A, Kip AE, Kirigi G, Sagaki P, Kimutai R, Were L, Omollo T, Egondi TW, Wasunna M, Alvar J, Dorlo TPC, and Alves F. Clinical Infectious Diseases 2018, ciy747, doi: 10.1093/cid/ciy747.
Recent development of visceral leishmaniasis treatments: successes, pitfalls, and perspectives by Alves F, Bilbe G, Blesson S, Goyal V, Monnerat S, Mowbray C, Muthoni Ouattara G, Pécoul B, Rijal S, Rode J, Solomos A, Strub-Wourgaft N, Wasunna M, Wells S, Zijlstra EE, Arana B, and Alvar J. Clinical Microbiology Reviews, August 2018
Visceral leishmaniasis relapse hazard is linked to reduced miltefosine exposure in patients from Eastern Africa: A population pharmacokinetic/pharmacodynamic study by Dorlo TPC, Kip AE, Younis BM, Ellis SJ, Alves F, Beijnen JH, Njenga S, Kirigi G, Hailu H, Olobo J, Musa AM, Balasegaram M, Wasunna M, Karlsson MO and Khalil EAG. Journal of Antimicrobial Chemotherapy 2017, doi:10.1093/jac/dkx283.
Safety and effectiveness of sodium stibogluconate and paromomycin combination for the treatment of visceral leishmaniasis in eastern Africa: Results from a pharmacovigilance programme by Kimutai R, Musa AM, Njoroge S, Omollo R, Alves F, Hailu A, Khalil EAG, Diro E, Soipei P, Musa B, Salman K, Ritmeijer K, Chappuis F, Rashid J, Mohammed R, Jameneh A, Makonnen E, Olobo J, Okello L, Sagaki P, Strub N, Ellis S, Alvar J, Balasegaram M, Alirol E, Wasunna M, Clinical Drug Investigation 2017, doi:10.1007/s40261-016-0481-0.
Efficacy and safety of AmBisome in combination with sodium stibogluconate or miltefosine and miltefosine monotherapy for African visceral leishmaniasis: Phase II randomized trial by Wasunna M, Njenga S, Balasegaram M, Alexander N, Omollo R, Edwards T, Dorlo TPC, Musa B, Sharaf Ali MH, Elamin MY, Kirigi G, Juma R, Anke E. Kip, Schoone GJ, Hailu A, Olobo J, Ellis S, Kimutai R, Wells S, Khalil EAG, Strub Wourgaft N, Alves F, Musa A. PLOS Neglected Tropical Diseases 2016, doi:10.1371/journal.pntd.0004880.
The Leishmaniasis East Africa Platform (LEAP): Strengthening clinical trial capacity in resource-limited countries to deliver new treatments for visceral leishmaniasis by Wasunna M, Musa, A, Hailu A, Khalil EAG, Olobo J, Juma R, Wells S, Alvar J, Balasegaram M. Transactions of the Royal Society of Tropical Medicine and Hygiene 2016, 1–3 doi:10.1093/trstmh/trw031.
Safety and efficacy of single dose versus multiple doses of AmBisome® for treatment of visceral leishmaniasis in Eastern Africa: A randomized trial by Khalil EAG, Weldegebreal T, Younis BM, Omollo R, Musa AM, Hailu W, Abuzaid A, Dorlo TPC, Hurissa Z, Yifru S, Haleke W, Smith PG, Ellis S, Balasegaram M, EL-Hassan AH, Schoone GJ, Wasunna M, Kimutai R, Edwards T, Hailu A. PLOS Neglected Tropical Diseases 2014, 8(1): e2613. doi:10.1371.
Validation of two rapid diagnostic tests for visceral leishmaniasis in Kenya by Mbui J, Wasunna M, Balasegaram M, Laussermayer A, Juma R, Njoroge Njenga S, Kirigi G, Riongoita M, de la Tour R, van Peteghem J, Omollo R, Chappuis F. PLoS Negl Trop Dis., September 2013.
Miltefosine: a review of its pharmacology and therapeutic efficacy in the treatment of leishmaniasis by Dorlo TPC, Balasegaram M, Beijnen JH, and de Vries PJ. Journal of Antimicrobial Chemotherapy, July 2012.
Single-dose liposomal amphotericin B (AmBisome®) for the treatment of visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial by Edwards T, Omollo R, Khalil EAG, Yifru S, Musa B, Musa A, Wasunna M, Smith PG, Royce C, Ellis S, Balasegaram M, Hailu A. Trials 2011, doi:10.1186/1745-6215-12-66.
Safety and Efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial by Omollo R, Alexander N, Edwards T, Khalil EAG, Younis BM, Abuzaid AA, Wasunna M, Njoroge N, Kinoti D, Kirigi G, PC Dorlo TPC, Ellis S, Balasegaram M and Musa AM. Trials 2011, doi:10.1186/1745-6215-12-166.
Paromomycin for the treatment of visceral leishmaniasis in Sudan: A randomized, open-label, dose-finding study by Musa A, Younis B, Fadlalla A, Royce C, Balasegaram M, Wasunna M, Hailu A, Edwards T, Omollo R, Mudawi M, Kokwaro G, El-Hassan A, Khalil E. PLoS Negl Trop Dis, October 2010, 4(10):e855
Geographical variation in the response of visceral leishmaniasis to Paromomycin in East Africa: A multicentre, open-label, randomized trial by Hailu A, Musa A, Wasunna M, Balasegaram M, Yifru S, Mengistu G, Hurissa Z, Hailu W, Weldegebreal T, Tesfaye S, Makonnen E, Khalil E, Ahmed O, Fadlalla A, El-Hassan A, Raheem M, Muellerm, Koummuki Y, Rashid J, Mbui J, Mucee G, Njoroge S, Manduku V, Musibi A, Mutuma G, Kirui F, Lodenyo H, Mutea D, Kirigi G, Edwards T, Smith P, Muthami L, Royce C, Ellis S, Alobo M, Omollo R, Kesusu J, Owiti R, Kinuthia J, for the Leishmaniasis East Africa Platform (LEAP) group. PLoS Negl Trop Dis, October 2010, 4(10):e709.
Events
2nd LEAP Scientific Conference
2-4 November 2021
Tenth EDCTP Forum
17-21 October 2021
13th Annual NTD Conference
4-6 December 2019
ECTMIH 2019
16-20 September 2019
25th LEAP Platform Meeting
3-4 October 2018
Ninth EDCTP Forum
17-21 September 2018
Videos
From neglect to hope: Voices of leishmaniasis
What is leishmaniasis?
LEAP Platform
KTN News Kenya: Visceral leishmaniasis documentaries (September 2019):
Killer diseases series:
Produced by MSF France, Allodocteurs, Réseau Canopé, Fondation Mérieux, universcience, Inserm, Institut Pasteur, and DNDi. Supported by les Investissements d’avenir.
Funding
This project (grant RIA2016S-1635) is part of the European and Developing Countries Clinical Trials Partnership Association (EDCTP2) programme supported by the European Union.
Other funding:
Other private foundations and individuals
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