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Collaboration for Prevention and Treatment of MDR Bacterial Infections

Periodic Reporting for period 1 - COMBINE (Collaboration for Prevention and Treatmentof MDR Bacterial Infections)

Reporting period: 2019-11-01 to 2020-10-31

Antimicrobial resistance (AMR) is the ability of a microorganism (such as bacteria, viruses, and some parasites) to stop an antimicrobial (such as antibiotics, antivirals and antimalarials) from working against it. New resistance mechanisms are emerging and spreading globally, threatening our ability to treat infectious diseases, which results in prolonged illness, disability, and death. The AMR Accelerator was created to respond to the challenge of developing new treatment and prevention approaches to AMR infections. More than 50 European partners are involved in the AMR Accelerator in seven different projects. The COMBINE project supports the coordination of the Accelerator projects. Additionally, COMBINE will propose innovative methods to optimize preclinical and clinical research for the development of products against AMR infections.
The work of COMBINE evolves around five work packages:

Coordinating the AMR Accelerator: COMBINE has set up a Coordination and Support Office (CSO) to coordinate the support of the Accelerator projects. The CSO has now established a Coordination Committee, a Communication Advisory Board, and an Ethics Advisory Board, that are playing key roles in overseeing progress in the AMR Accelerator.

Achieving effective management of scientific data: COMBINE has developed a robust data management process and will continue to refine this process. The software developed within COMBINE will support a wide range of data formats, from simple office documents and chemical structures to preclinical and clinical data sets, while retaining compatibility with all common operating systems. Documentation covering data governance, quality, access, and analysis procedures has been developed and will be transferred to the projects within the Accelerator.

Managing the communication: COMBINE will work to strengthen the interaction between AMR Accelerator participants and AMR stakeholders across the EU and globally. COMBINE has already established a strong AMR Accelerator identity, with project logos and an engaging and informative joint website. COMBINE has and will continue to coordinate media outreach and social media activities and communicate results. In 2020, COMBINE has organized participation at two key conferences, bringing together information about the individual projects and presenting the strategy and structure of this unique public private partnership.

Improving clinical trials: COMBINE will help increasing the success rate of vaccine and antibiotic trials by proposing innovative study designs and novel strategies to analyse clinical trial data. This will be achieved by analysing data from completed preclinical and clinical studies for AMR products. To this end, COMBINE has issued an open data call within the AMR community, and is actively engaging with parties interested in sharing their data. To identify current gaps in vaccine development and to guide the data analysis work, a review of literature on vaccines for nosocomial AMR pathogens was published (Frontiers in Immunology, https://doi.org/10.3389/fimmu.2020.01755) and a vaccine experts workshop is in preparation.

Standardising an animal infection model: COMBINE will develop a standardised protocol for a rodent infection model, establish a repository of reference bacterial strains, and provide a framework to make use of collected data to improve translation to the clinic via mathematical modelling approaches. The standard protocols will help harmonise the body of non-clinical information and allow for better predictions of efficacy in the human population. COMBINE has prepared a webinar on animal infection models with the intention to gather feedback from AMR Accelerator partners on animal model of choice for this work. A commitment to an animal infection model (e.g. lung) to focus on will be made based on this information and further engagement with experts across the field in a workshop in 2021. An ongoing literature review will form the basis for advancing translation from preclinical to clinical phases for a given indication.
Despite a challenging year for many partners with the COVID-19 pandemic, and some resulting minor delays, the COMBINE project is on track to deliver on overall milestones and objectives in both the coordination and support role and in our scientific mission.

Expected results until the end of the project and potential impacts
Network: A knowledge base and interpersonal network will develop between AMR Accelerator participants and AMR stakeholders across the EU and globally, which will be important for future contacts and potential collaborations in the AMR community. COMBINE will be instrumental in ensuring that these ties will remain.
Improving clinical trials and standardising animal models: COMBINE will contribute to improve design of clinical trials and develop more predictive and reliable infection models for preclinical studies, to accelerate antibacterial drug and vaccine development.
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