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A multi-arm, multi-stage trial for cutaneous leishmaniasis - MAMS4CL

Objective

Cutaneous leishmaniasis (CL) is a neglected tropical disease affecting more than one million people globally each year. In Ethiopia alone more than 40,000 people are thought to be affected annually. Infection results in stigmatising, visible, chronic, scarring skin lesions which cause permanent morbidity and significantly affect mental health, household financial stability and life chances.

There is a major need for new therapeutics for CL. The current first line therapy is intramuscular sodium stibogluconate. Treatment is often ineffective, painful, and associated with adverse effects. The complexities of administration mean treatment is restricted to a small number of centralised facilities. As a result the majority of patients receive no treatment.

There are a number of promising alternative and novel therapeutics for cutaneous leishmaniasis which may be more effective, more tolerable and more suitable for widespread scale up. However the evidence for these therapies is lacking and this vacuum means that policy cannot be easily changed.

Our consortium of leading European and African research institutions proposes a step-change in the evidence base for CL. We will use a multi-arm, multi-stage randomised trial – MAMS4CL - to simultaneously evaluate multiple novel therapeutic interventions. This approach will reduce the time required to identify optimal treatment strategies for CL and transform the therapeutic landscape. We will identify and test five candidate interventions and assess their safety, efficacy, cost-effectiveness, and acceptability. The interventions have been selected as they offer: more tolerable administration, shorter treatment duration or home-based therapy. We will embed within MAMS4CL detailed pharmacokinetic, health economic and social science studies to provide a comprehensive analysis to inform regulators, policy makers and programmes.

Fields of science (EuroSciVoc)

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Keywords

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Programme(s)

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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.

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.

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.

(opens in new window) HORIZON-JU-GH-EDCTP3-2024-01-two-stage

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Coordinator

LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER
Net EU contribution

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.

€ 859 060,00
Address
KEPPEL STREET
WC1E 7HT London
United Kingdom

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Region
London Inner London — West Camden and City of London
Activity type
Higher or Secondary Education Establishments
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Total cost

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.

€ 859 060,00

Participants (6)

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