Objective
Artemisinin resistant Plasmodium falciparum is spreading alarmingly in Sub-Saharan Africa (SSA) and has compromised the efficacy of artemether lumefantrine. To meet this threat to malaria elimination, the WHO has recommended multiple first line treatments i.e. simultaneous use of several artemisinin-based combinations. Artesunate amodiaquine (ASAQ) is a clear choice for inclusion but there is currently no child-friendly formulation.
Taste mask coated ASAQ micro pellets (MPs) have been developed using a patented technology, MicroCoatTM. They are palatable, easy to administer, offering dosing flexibility and an innovative child-friendly solution. We aim to advance the development of ASAQ_MPs by: (i) performing a field trial in Malawi, and (ii) charting a path to WHO prequalification & commercialisation.
GMP quality ASAQ_MP clinical batches will be compared to standard ASAQ tablets in a randomised trial of under-5 children with acute P. falciparum to assess: (i) desethylAQ exposure, 28-day efficacy, tolerability & acceptability (n=39/arm), and (ii) transmission blocking efficacy by direct membrane feeding: ASAQ_MPs vs. ASAQ_MPs + flavoured single-low-dose primaquine (SLDPQ), including PQ & carboxyPQ PK (n=26/arm). If ASAQ MP-tablet desethylAQ exposures are bioequivalent, this will inform ASAQ_MP dosing in a future pivotal bioequivalence study.
A robust pathway to impact strategy will: (i) raise awareness of ASAQ_MPs amongst malaria control programmes and key international organisations (e.g. WHO), especially for the under-5 vulnerable group, and (ii) determine how best to achieve WHO prequalification. Manufacturers in Low- and middle-income countries, including those in SSA, will be engaged for future technology transfer and commercialisation of ASAQ_MP. MicroCoatTM innovative technology could also be applied to paediatric HIV and TB.
Fields of science (EuroSciVoc)
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.2.1 - Health
MAIN PROGRAMME
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Topic(s)
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-JU-GH-EDCTP3-2025-04-two-stage
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
OX1 2JD Oxford
United Kingdom
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.