Periodic Reporting for period 2 - ECRAID-Base (European Clinical Research Alliance on Infectious Diseases)
Período documentado: 2022-09-01 hasta 2024-02-29
Infectious diseases pose a serious threat to global health and economies. Common infections caused by known pathogens have a large impact on societies around the world, especially vulnerable patient groups, leaving much ground to win by improving diagnostic, preventive and therapeutic strategies. The rise of antimicrobial resistance, with strains resistance to existing treatments appearing at an increasing rate, has further complicated efforts.
At the same time, the potential impact of (re)emerging new/unknown pathogens has been amplified by global trends such as population growth, increases in trade and travel, urbanisation, deforestation, and climate change. The COVID-19 pandemic exposed serious shortcomings in Europe’s fragmented clinical research response that result in inefficiencies and delays society can no longer accept.
The ECRAID-Base project was developed to overcome (some of) these problems. It is intended to implement the core set of activities of Ecraid – a pan-European ‘warm-base’ clinical research network for infectious diseases. Over the five-year duration of ECRAID-Base, Ecraid will be established as a self-sustaining, not-for-profit organisation conducting clinical research with both public and private sponsors.
At the heart of Ecraid’s approach is a ‘warm-base’ clinical trial network developed under two previous EC-funded projects, COMBACTE and PREPARE. It encompasses over 2,000 sites in more than 40 European countries, including primary care settings (general practitioners), hospital settings (emergency rooms and intensive care units), paediatric care settings, diagnostic laboratories and long-term care facilities. With this clinical research network, Ecraid aims to innovate clinical trial methodology and to conduct trials faster and more cost-effective.
As part of ECRAID-Base, five perpetual observational studies and one adaptive platform trial tackle serious medical conditions, such as complicated urinary tract infections, ventilator-associated pneumonia, community-acquired pneumonia, acute respiratory infections, and unexplained febrile illness. Unlike conventional trials, these studies are able to accommodate new research questions related to diagnosis, treatment and prevention of the named infections throughout their duration, preparing this ‘warm-base’ to respond efficiently, especially during outbreaks and pandemics.
At the same time, the potential impact of (re)emerging new/unknown pathogens has been amplified by global trends such as population growth, increases in trade and travel, urbanisation, deforestation, and climate change. The COVID-19 pandemic exposed serious shortcomings in Europe’s fragmented clinical research response that result in inefficiencies and delays society can no longer accept.
The ECRAID-Base project was developed to overcome (some of) these problems. It is intended to implement the core set of activities of Ecraid – a pan-European ‘warm-base’ clinical research network for infectious diseases. Over the five-year duration of ECRAID-Base, Ecraid will be established as a self-sustaining, not-for-profit organisation conducting clinical research with both public and private sponsors.
At the heart of Ecraid’s approach is a ‘warm-base’ clinical trial network developed under two previous EC-funded projects, COMBACTE and PREPARE. It encompasses over 2,000 sites in more than 40 European countries, including primary care settings (general practitioners), hospital settings (emergency rooms and intensive care units), paediatric care settings, diagnostic laboratories and long-term care facilities. With this clinical research network, Ecraid aims to innovate clinical trial methodology and to conduct trials faster and more cost-effective.
As part of ECRAID-Base, five perpetual observational studies and one adaptive platform trial tackle serious medical conditions, such as complicated urinary tract infections, ventilator-associated pneumonia, community-acquired pneumonia, acute respiratory infections, and unexplained febrile illness. Unlike conventional trials, these studies are able to accommodate new research questions related to diagnosis, treatment and prevention of the named infections throughout their duration, preparing this ‘warm-base’ to respond efficiently, especially during outbreaks and pandemics.
Despite the ongoing COVID-19 pandemic, the first 36 months of the project saw major progress towards achieving the project’s goals.
A comprehensive legal structure was created to facilitate the transition of staff, projects and operations from the University Medical Center Utrecht to the newly established Ecraid foundation. The foundation operates from its headquarters in Utrecht, the Netherlands. It also has a fully functional website and active social media channels, which are used for publishing and dissemination of foundation-, project-, and study-level communication.
The five perpetual observational studies (POS) are actively recruiting patients in 170 sites in 24 European countries. At the end of RP2 4753 patients had been enrolled. The protocol for a sixth POS (for Yeast infections) has been completed and seeking funding. All POS are connected through uniform data collection tools, with a uniform master Data Management Plan that describes the project’s general data management policy, and a harmonised electronic Case Report Form.
Together with the ongoing REMAP-CAP study (in 130 sites in Europe) Ecraid will be able to immediately respond to any new outbreak of Acute Respiratory Infections, such as influenza. Moreover, the network was used twice during the second reporting period to rapidly collect epidemiological data on mycoplasma infections and infections caused by a hypervirulent carbapenem-resistant Klebsiella pneumoniae.
A comprehensive legal structure was created to facilitate the transition of staff, projects and operations from the University Medical Center Utrecht to the newly established Ecraid foundation. The foundation operates from its headquarters in Utrecht, the Netherlands. It also has a fully functional website and active social media channels, which are used for publishing and dissemination of foundation-, project-, and study-level communication.
The five perpetual observational studies (POS) are actively recruiting patients in 170 sites in 24 European countries. At the end of RP2 4753 patients had been enrolled. The protocol for a sixth POS (for Yeast infections) has been completed and seeking funding. All POS are connected through uniform data collection tools, with a uniform master Data Management Plan that describes the project’s general data management policy, and a harmonised electronic Case Report Form.
Together with the ongoing REMAP-CAP study (in 130 sites in Europe) Ecraid will be able to immediately respond to any new outbreak of Acute Respiratory Infections, such as influenza. Moreover, the network was used twice during the second reporting period to rapidly collect epidemiological data on mycoplasma infections and infections caused by a hypervirulent carbapenem-resistant Klebsiella pneumoniae.
The ultimate goal of the ‘warm-base’ academic clinical trial network established through ECRAID-Base is to enhance the efficiency of clinical trials on infectious diseases addressing the global health problem of antimicrobial resistance as well as to build the capacity to rapidly, effectively and efficiently respond to infectious disease outbreaks in Europe and pandemics.
The design and methodology of the REMAP-CAP trial are a prime example of progress beyond the state-of-the-art in clinical trial methodology and international collaboration. The perpetual observational studies will provide the infrastructure to embed more innovative trial design elements. The Ecraid network is increasingly developing teaching activities to educate and engage the next generation of researchers in infectious diseases, which will boost European societies’ protection from social and economic disruption linked to infectious diseases.
The design and methodology of the REMAP-CAP trial are a prime example of progress beyond the state-of-the-art in clinical trial methodology and international collaboration. The perpetual observational studies will provide the infrastructure to embed more innovative trial design elements. The Ecraid network is increasingly developing teaching activities to educate and engage the next generation of researchers in infectious diseases, which will boost European societies’ protection from social and economic disruption linked to infectious diseases.