ECRAID-Base: European Clinical Research Alliance on Infectious Diseases
Trial Aim
ECRAID-Base aims to establish a long-term, self-sustainable Pan-European clinical research network.
This infrastructure would advance research in developing new diagnostic, preventive, and therapeutic strategies for managing infectious diseases. It will also facilitate in delivering much faster, more efficient and cost-effective clinical research against emerging infectious diseases (EID) and antimicrobial resistance (AMR).
Participant Information Documents
POS-ARI- PC-001: Click here to download the Participant Information Sheet.
Contact details
Funding details
Funding
POS-ARI-PC Audit: European Union’s Horizon 2020 research and innovation
POS-ARI-PC CORE: European Union’s Horizon 2020 research and innovation
POS-ARI-PC-001: Sanofi
Sponsor
POS-ARI-PC Audit: University Medical Center Utrecht (UMCU), the Netherlands
POS-ARI-PC CORE: Ecraid
POS-ARI-PC-001: EcraidBackground and Study Aims
Currently, there is a lack of international collaboration, resulting in fragmentation and isolation of research efforts, inefficient use of scarce research resources, and suboptimal response to infectious diseases.
Therefore, this perpetual Observational study will help generate rigorous evidence to improve the diagnosis, prevention, and treatment of infectious diseases. The infrastructure would be equipped to respond to public health threats effectively and rapidly through the collaboration of many different European countries and industry partners.
What are the possible risks and benefits of participating?
No risks to participants taking part in this study.
Participants may not personally benefit from taking part but will help inform researchers and doctors in identifying best practices for the diagnosis and management of acute respiratory tract infections. Thereby they are potentially helping society as a whole, not just their country, but also Europe and possibly the world.
POS-ARI-PC-001 (Currently Recruiting)
The POS-ARI-PC platform supports the efficient set-up of new clinical studies and trials, which will be embedded into this platform. One such addition to this research-ready infrastructure is an embedded study called POS-ARI-PC-001 which started in February 2024. POS-ARI-PC-001 is a prospective, multi-center, multi-country observational study in up to 5 European countries that will be conducted for 12 consecutive months and with an aim to recruit a total of approximately 2,000 participants.
The aim of the POS-ARI-PC-001 study is to estimate overall incidences of medically-attended Respiratory Syncytial Virus Infection (RSV), Human Metapneumovirus (HMPV), Human Parainfluenza Viruses (HPIV) and Rhinovirus (RV) in adults 60 years and over, and also to compare between sites and countries. These viruses are a common cause of worldwide respiratory illness burden, morbidity, and with mortality particularly in older adults and immuno-compromised individuals. Therefore, this study will help make decisions about vaccine development, evaluation, and procurement.
Who Can Participate?
What does the study involve?
The participants will be enrolled at participating GP practices across Europe when they present with symptoms of an acute respiratory infection. A baseline assessment would be completed and a combined throat and nose swab will be taken for study purposes. During the course of the study, participants will also need to complete an online/paper diary for 14 days.
Participants may also be invited for a qualitative interview that is entirely optional. This is to better understand their overall experience of taking part and their perspectives on this study.
POS-ARI-PC AUDIT (23/24 Period Closed)
The main aim of the POS-ARI-PC AUDIT study is to investigate the presentation and management (including clinical examination and diagnostic procedures routinely undertaken, medication prescribing and advice given) for Acute Respiratory Infections (ARI) in primary care (PC). This is an ‘audit-type’ study in which clinicians register non-identifiable characteristics of patients and their management. Describing current practice of ARI in contrasting European countries and settings will allow identification of (unwarranted) variation in care, and estimation of congruence of current practice with best-practice guidelines to identify opportunities for improvements in management.
Who Can Participate?
POS-ARI-PC AUDIT: Armenia, Belgium, Croatia, France, Georgia, Ireland, Moldova, Netherlands, Norway, Poland, Romania, Spain, Sweden and UK
POS-ARI-PC Core (Currently Recruiting)
POS-ARI-PC Core is a prospective, observational study of ARI patients in primary care where a sample from the participant will be collected upon inclusion. The participant can then be followed up for 28 days to capture the aetiology of their ARI and describe clinical outcomes.
In addition, there will be a qualitative study with research professionals, clinicians and patients to gain a deep understanding of the research process and to explore the views and experiences of patients who consult European primary care services for ARI symptoms.
Who Can Participate?
Eligible patients will be of any age with:
- Symptoms suggestive of an acute lower respiratory infection with cough as the predominant symptom, with illness duration ≤7 days
AND/OR
- Symptoms suggestive of an acute upper respiratory infection with sore throat and/or coryza as the predominant symptom, with illness duration ≤7 days
AND/OR
- Other symptoms suggestive of COVID-19, Influenza, RSV
POS-ARI-PC Core: Belgium
TRIAL TEAM
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Ellie Newbury
Assistant Trial Manager
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Emma Harper
Trial Manager
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Yenabeb Ayalew
Clinical Trial Administrator
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Fiona Mowbray
Qualitative Researcher
OXFORD CO-INVESTIGATORS
EXTERNAL CO-INVESTIGATORS
Related Publications
Zaeck, L.M., Lamers, M.M., Verstrepen, B.E. et al. Low levels of monkeypox virus-neutralizing antibodies after MVA-BN vaccination in healthy individuals. Nat Med 29, 270–278 (2023). https://doi.org/10.1038/s41591-022-02090-w
Hassoun-Kheir N, van Werkhoven CH, Dunning J, Jaenisch T, van Beek J, Bielicki J, Butler CC, Francois B, Harbarth S, Hernandez Padilla AC, Horby P, Koopmans M, Lee J, Rodriguez-Baño J, Tacconelli E, Themistocleous Y, van der Velden AW, Bonten M, Goossens H, de Kraker MEA; ECRAID-Base consortium. Perpetual observational studies: new strategies to support efficient implementation of observational studies and randomized trials in infectious diseases. Clin Microbiol Infect. 2022 Dec;28(12):1528-1532. doi: 10.1016/j.cmi.2022.07.024. Epub 2022 Aug 5. PMID: 35940566; PMCID: PMC9354481.
van Beek Janko, Fraaij Pieter LA, Giaquinto Carlo, Shingadia Delane, Horby Peter, Indolfi Giuseppe, Koopmans Marion, Acute hepatitis study group. Case numbers of acute hepatitis of unknown aetiology among children in 24 countries up to 18 April 2022 compared to the previous 5 years. Euro Surveill. 2022;27(19):pii=2200370. https://doi.org/10.2807/1560-7917.ES.2022.27.19.2200370