ECRAID-Base
European Clinical Research Alliance on Infectious Diseases – Base
What is ECRAID-Base?
There has historically been a lack of international collaboration in research into infectious diseases, resulting in fragmentation and isolation of research efforts, inefficient use of scarce research resources, and suboptimal response to contagion.
The ECRAID-Base project provides the foundation for the European Clinical Research Alliance on Infectious Diseases (ECRAID), a long-term, self-sustainable, pan-European clinical research network, that will ensure that public health authorities will be equipped to respond to public health threats on the scale of the COVID-19 pandemic effectively and rapidly through the collaboration of many different European countries and industry partners.
Further information about the objectives of ECRAID can be found in the videos below and on the central ECRAID website:
ecraid.eu/projects/ecraid-base
Perpetual observation studies
ECRAID-Base supports five "perpetual observation studies" (POS) across Europe. These address infections relevant for antimicrobial resistance (AMR), such as ventilator-associated pneumonia and complicated urinary tract infections, as well as for emerging infectious diseases (EID) like acute respiratory infections. All of the POS will eventually mature into adaptive platform trials with the capability to rapidly respond to public health threats.
The University of Oxford's Primary Care Clinical Trials Unit (PCCTU) is presently taking part in one of the perpetual observation studies in the ECRAID-Base project: POS-ARI-PC.
Contact Details
Oxford Email:
Participant Information Documents
The POS-ARI-PC Study
Acute respiratory tract infection is the most common reason for consulting in primary care sites, such as general practices (GPs), urgent care centres, and paediatric care centres. Moreover, new and re-emerging pathogens are often first noticed in primary care.
POS-ARI-PC is a multi-country, prospective perpetual observational study (POS) among patients with symptoms of an acute respiratory tract infection (ARI) presenting in primary care (PC) – hence "POS-ARI-PC".
It aims to provide an estimate of the overall incidence of illness and individual diagnoses, as well as critically important benchmark descriptive data related to patient characteristics, complications, outcome, and risk factors. These data allow for the identification of variation in management and care within and between countries in Europe, suggesting improvements for care planning and informing clinical guidelines.
The study will also establish a research-ready infrastructure for enhanced observational studies and clinical trials related to treatment, diagnosis, and prevention of ARI in the primary care setting. Such a "plug-in" approach is especially beneficial during epidemics and pandemics because it makes it possible to set up new studies much quicker, without having to go through the full process of regulatory approvals for each individual research.
The PCCTU is presently playing a leading role in the first such "plug-in" embedded study, POS-ARI-PC 001, as well as two studies central to the overall functioning of the POS-ARI-PC infrastructure, POS-ARI-PC Core and POS-ARI-PC Audit.
You can find updates on how recruitment for each of these studies is progressing on the central ECRAID website for POS-ARI-PC:
POS-ARI-PC Core
POS-ARI-PC Core is the protocol that forms the core structure of POS-ARI-PC, as implied by its name. When a new embedded observational study or randomised control trial is added to POS-ARI-PC, this will be appended to the POS-ARI-PC Core protocol and all appropriate approvals will be gained for each new appendix.
The study itself is non-randomised, prospective, detailed observational study aiming to understand the causes, management practices, and outcomes of ARIs in primary care. The detailed data collected will help ensure research readiness for including embedded observational and randomised evaluations to answer questions about the effectiveness of diagnostic, behavioural or therapeutic management strategies for ARI in PC.
What does the study involve?
Participants will be enrolled at participating GP practices across Europe when they present with symptoms of an acute respiratory infection. A baseline assessment will be completed and a combined throat and nose swab will be taken for study purposes. Participants will be asked to complete an online/paper diary for 14 days, with a further 14 days of follow-up with the research team. Participation in the study will therefore last for 28 days in total.
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.
Please read the Participant Information Sheet (excluding the POS-ARI-PC-001 appendix) in the link above for more detailed information on the trial.
Trial status: Recruiting
Who Can Participate?
The POS-ARI-PC Core study is presently only seeking participants in Belgium.
Eligible participants are of any age with:
- Symptoms suggestive of an acute upper respiratory infection with a sore throat, a new or increased cough, and/or coryza (runny or stuffy nose or sneezing) as the predominant symptom, with your illness having lasted up to 7 days.
AND/OR
- Other symptoms suggestive of COVID-19, Influenza, or RSV.
POS-ARI-PC-001
The POS-ARI-PC platform supports the efficient set-up of new embedded clinical studies and trials. 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-centre, multi-country observational study in 5 European countries, including the UK, that is being conducted for 12 consecutive months and aims 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 aged 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.
What does the study involve?
The structure of the POS-ARI-PC-001 trial is the same as the POS-ARI-PC Core trial, with several minor changes to study procedure and different participation criteria.
Participants will be enrolled at participating GP practices across Europe when they present with symptoms of an acute respiratory infection. A baseline assessment will 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, with a further 14 days of follow-up with the research team and completion of a quality of life questionnaire. Participation in the study will therefore last for 28 days in total.
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.
Please read the Participant Information Sheet (including the POS-ARI-PC-001 appendix) in the link above for more detailed information on the trial.
Trial status: Recruiting
Trial duration: Feb 2024 - Mar 2025
Who Can Participate?
You may be eligible to take part in the POS-ARI-PC-001 study at sites in the UK and France if you are:
- 60 years of age and over
- 50 to 59 years of age with an long-term health condition qualifying you for an influenza vaccination
AND
- Have symptoms suggestive of an acute upper respiratory infection with a sore throat, a new or increased cough, and/or coryza (runny or stuffy nose or sneezing) as the predominant symptom, with your illness having lasted up to 10 days.
POS-ARI-PC Audit
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 anonymous audit in which clinicians document non-identifiable characteristics and management of around 3,500 primary care patients over the study period. 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.
What does the study involve?
The present audit is a "paper exercise" with GPs recording the patients they see with respiratory tract infection symptoms. The data is then entered into an online data capture tool, either by the GPs themselves or by a member of the primary care network coordinating team in their respective countries.
Trial status: Next audit from Dec 2024 – Mar 2025
Who Can Participate?
The POS-ARI-PC Audit study involves primary care providers in Armenia, Belgium, Croatia, Denmark, France, Georgia, Germany, Greece, Hungary, Ireland, Moldova, the Netherlands, Norway, Poland, Romania, Spain, Sweden and the UK.
As an anonymised audit of existing records, the study does not seek individual participation.
TRIAL TEAM
-
Nguyen Tran
Senior Trial Manager
-
Emma Harper
Trial Manager
-
Sarah Tonkin-Crine
Associate Professor & Health Psychologist
-
Fiona Mowbray
Qualitative Researcher
OXFORD CO-INVESTIGATOR
-
Chris Butler
Professor of Primary Care
EXTERNAL CO-INVESTIGATOR
Assistant Professor, University Medical Center Utrecht
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: EcraidREC: 23/EE/0050
IRAS: 324504
Registration: ISRCTN10204126
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