ExpectedOutcome:
Proposals under this topic should aim to deliver results that are directed, tailored towards, and contributing to the following expected outcomes. Proposals need to address at least two of these, with the first bullet point being compulsory:
- Improvement of the use of existing antimicrobials to reduce AMR and providing data contributing to their equitable access in sub-Saharan Africa, and/or the advancement of late-stage clinical R&D of novel antimicrobials with improved properties (efficacy, safety, resistance pattern, useability) in the clinical trials pipeline;
- Data about development and implementation of antimicrobial stewardship (AMS) processes to optimise the use of antimicrobial medicines in human health and reduce antimicrobial resistance (AMR), employing the One Health approach;
- Effective infection prevention control measures, sanitation and hygiene to reduce the need for and the use of antimicrobial medicines.
Scope:
Background:
The WHO has declared that AMR is one of the top 10 global public health threats facing humanity. Each year, at least 1.27 million people die as a consequence of AMR, with Africa having the world’s highest mortality rate from AMR infections, resulting in over 27 deaths per 100,000[1]. Without action, the death toll could rise even higher, to as many as 10 million deaths annually by 2050.[2]
Tackling AMR requires multi-modal interventions, the collaboration of many disciplines and countries. According to the Organisation for Economic Co-operation and Development (OECD), measures to prevent infections such as vaccinations, promoting hand hygiene and better hygiene in health-care facilities more than halves the risk of death and decreases the health burden of AMR. Antimicrobial stewardship (AMS) could further reduce the burden of drug-resistant infection[3]. The WHO defines AMS as a coherent set of integrated actions which promote the responsible and appropriate use of antimicrobials to help improve patient outcomes across the continuum of care. Responsible and appropriate use of antimicrobials includes prescribing only when needed, selection of the optimal drug regime, drug dosing, route of administration and duration of treatment following proper and optimized diagnosis. These actions are complemented by the implementation of infection prevention and control (IPC), enhancing water, sanitation and hygiene (WASH), and optimizing vaccination coverage.[4]
AMR is one of the Global Health issues which can hugely benefit from the employment of the One Health approach. The One Health approach is defined as a joint effort of various disciplines that come together to provide solutions for human, animal, and environmental health, including food safety[5]; more information can also be found in the Global research priorities agenda for One Health AMR[6]. AMR transmission is a critical global problem affecting humans, the environment, and animals. Hence, proposals need to have the One Health approach at their centre.[7]
Furthermore, the availability and access to existing antibiotics is also a challenge[8]. The Global Leaders Group on AMR recently established that the world faces a serious antibiotic pipeline and access crisis that requires innovative financing measures. In particular, efforts to ensure equitable access to antibiotics in LMICs that experience the highest burden of AMR, are needed.
Scope:
Proposals must address at least two of the following areas, with the delivery of the first bullet point being compulsory:
- Conduct R&D on the better use of existing antimicrobials to reduce AMR and provide data to contribute to their equitable access in SSA, and/or conduct late-stage clinical R&D on novel antimicrobials with improved properties (efficacy, safety, resistance pattern, useability) for infections within the scope of EDCTP3 to reduce AMR;
- Develop innovative antimicrobial stewardship strategies in human health on how to tackle AMR based on the One Health approach within the scope of EDCTP3 in SSA;
- Develop and implement cost effective, acceptable and feasible infection prevention and control (IPC) strategies, in reducing AMR in healthcare facilities and communities.
Only proposals focusing their research on existing and/or novel antimicrobials from phase 3 onwards will be eligible. Neither pre-clinical research nor early-stage clinical trials in the context of product development are within the scope of this call.
The inclusion of industry partners involved in the development and/or manufacturing of the antimicrobials in the consortium is strongly encouraged.
Where possible, collaboration and coordination with the Team Europe Initiative on Sustainable Health Security in Africa or Manufacturing and health products (TEI-MAV+) is encouraged. The applicants could show, for example, willingness to enter into technology transfer agreements with African counterparts - including the provision of patents, technical knowledge and know-how -, or early engagement with regulators or with African manufacturers to support the translation into affordable products adapted to the regional market.
Environmental aspects relating to antimicrobial resistance in the production of antimicrobials and the waste of antimicrobials should be considered.
For the purposes of this call, existing antimicrobials are classified as those already on the market, but impacted by AMR, and in need of improvement of their use to minimise AMR, whilst by novel antimicrobials we refer to those in the clinical trial development pipeline, but not yet on the market.
Proposals should assess the impact, contribution, utility, accessibility, equity and cost-effectiveness of proposed interventions on AMR across socioeconomic settings in SSA.
Sepsis is included in the scope of this call. According to the Berlin Declaration on Sepsis, calling upon the enforcement of the WHA70.7 resolution, sepsis should be tackled as part of actions against AMR to maximise efficiencies and reduce the burden of disease.[9]
Applicants are encouraged to work among international sectors and actors, including human and veterinary medicine, agriculture, finance and environment experts.
Applicants need to concisely describe any proven research evidence of previous findings and explain how the proposal builds on these results.
Proposals should present a sound assessment of the feasibility of the proposed work, in particular as regard to the proposed clinical interventions. Realistic plans for recruitment of subjects (as part of the clinical trial plan with projected dates) should be presented and documented by demonstrated success from previous studies. The proposals should justify the choice of populations to be enrolled into the interventions. Relevant determining characteristics (such as socio-economic status) also need to be considered.
Proposals must assure that the clinical trials are conducted in line with national and international standards of research, to comply with current legislation, good clinical practice, ethics, and safety-related issues, as well as good manufacturing practice, as relevant.
Proposals should describe how stakeholder views of the proposal’s relevance and the study design have been incorporated into the work plan of the research proposal. Proposals should indicate explicitly the plans for good participatory practices for engaging stakeholders at every step of the research life cycle.
Proposals should provide details on the methodology for linking clinical research aspects with the translation into healthcare practice and policy.
For all proposed research activities, attention should be paid to critical social factors such as sex, gender, age, socio-economic factors, ethnicity/migration, and disability both in terms of the consortium composition and the selection of study participants. Vulnerable populations need to be included in the clinical study population, including children, pregnant women, people with co-infections and comorbidities, older people and people living in hard-to-reach communities (unless excluded for physiologic or metabolic reasons).
FAIR data principles and open access of publications are required.
All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate.
Applicants are reminded of the expectation that proposals should come from research consortia with a strong representation of institutions and researchers from sub-Saharan African countries, including involvement of Franco/Lusophone countries if possible. Applicants are also reminded of the expectation of reaching out to organisations in countries with relatively lower research capacities.
[1] The Lancet AMR analysis: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02724-0/fulltext
[2] World Bank, Antimicrobial Resistance: https://www.worldbank.org/en/topic/health/brief/antimicrobial-resistance-amr and Global AMR R&D Hub and WHO, Incentivising the development of new antibacterial treatments 2023: https://globalamr.e-laborat.eu/incentivising-the-development-of-new-antibacterial-treatments-progress-report-by-the-global-amr-rd-hub-and-who/
[3] OECD, Stemming the Superbug Tide: https://www.oecd.org/els/stemming-the-superbug-tide-9789264307599-en.htm; Antimicrobial stewardship programmes in health-care facilities in low-and middle-income countries: a WHO practical toolkit: https://www.who.int/publications/i/item/9789241515481; A European One Health Action Plan against Antimicrobial Resistance (AMR): https://health.ec.europa.eu/antimicrobial-resistance/eu-action-antimicrobial-resistance_en#ref-2017-eu-one-health-action-plan-against-amr; Antimicrobial stewardship: can we add pharmacovigilance networks to the toolbox? https://link.springer.com/article/10.1007/s00228-020-03035-3
[4] WHO policy guidance on integrated antimicrobial stewardship activities: https://www.who.int/publications/i/item/9789240025530;
WHO Global research agenda for antimicrobial resistance in human health: https://www.who.int/publications/m/item/global-research-agenda-for-antimicrobial-resistance-in-human-health;
Global Action Plan on Antimicrobial resistance:
https://www.who.int/publications/i/item/9789241509763
[5] Antimicrobial resistance: global report on surveillance: https://iris.who.int/handle/10665/112642;
Council recommendation published in June 2023: https://www.consilium.europa.eu/en/press/press-releases/2023/06/13/tackling-antimicrobial-resistance-council-adopts-recommendation/#:~:text=Overall%2C%20the%20Council's%20recommendation%20seeks,become%20resistant%20to%20medical%20intervention
[6] WHO Global One Health priority research agenda for antimicrobial resistance: https://iris.who.int/bitstream/handle/10665/370279/9789240075924-eng.pdf?sequence=1
[7] ILRI One Health Strategy: Stopping the global rise of high-impact zoonotic disease, foodborne disease and antimicrobial resistance: https://cgspace.cgiar.org/bitstream/handle/10568/125264/OneHealthStrategy.pdf?sequence=1&isAllowed=y
[8] Progress report by the Global AMR R&D Hub and WHO 2023:
https://globalamr.e-laborat.eu/incentivising-the-development-of-new-antibacterial-treatments-progress-report-by-the-global-amr-rd-hub-and-who/;
The Global Response to AMR, Wellcome Trust: https://wellcome.org/sites/default/files/wellcome-global-response-amr-report.pdf
[9] 2023 Berlin Declaration on Sepsis: https://www.esaic.org/esa-news/the-2030-world-sepsis-declaration/#:~:text=The%20Berlin%20Declaration%20on%20Sepsis%20is%20an%20urgent%20call%20for,reinvigorated%20global%20action%20on%20sepsis
Expected Impact:
Activities funded under the 2024 work programme of the Global Health EDCTP3 JU calls for proposals should contribute to:
- reduce the individual, social, and economic burdens of infectious diseases in sub-Saharan Africa through the development and uptake of new or improved interventions, and
- increase health security in sub-Saharan Africa and globally by reducing the risk of outbreaks and pandemics and enhancing national and regional capacity to address antimicrobial resistance.
- Progressing towards the achievement of SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’ in sub-Saharan African (SSA) countries;
- Enable the implementation of the short- and medium-term actions foreseen by the AU EU Innovation Agenda (adopted in July 2023) in the area of public health and the EU Global Health Strategy (November 2022);
- Improve equitable access to a full range of essential health services from health promotion to disease prevention and affordable quality treatment, rehabilitation and palliative care to fight communicable diseases;
- Expand partnerships based on equal footing, co-ownership, mutual interest and strategic priorities;
- Provide evidence for informed health policies and guidelines within public health systems in SSA and at international level;
- Enhance sustainable global scientific collaboration in health research and international cooperation across SSA;
- Develop novel, innovative HIV therapeutics for reducing the disease burden of HIV in SSA
- Research on existing Malaria vaccines and development of new promising candidates
- Accelerating development and integration of therapeutics against neglected tropical diseases (NTDs) in SSA;
- Tackle Antimicrobial Resistance (AMR) through R&D in novel and existing antimicrobials
- Develop new tools, technologies and approaches for vector control in SSA;
- Develop innovative digital health solutions for SSA.
- Build appropriate local capacity.
