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.
The ECRAID-Base project provides the foundation for the European Clinical Research Alliance on Infectious Diseases (ECRAID), a long-term, self-sustainable, clinical research network across Europe.
This will ensure that public health authorities are 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 studies are looking at infections that are relevant to antimicrobial resistance (AMR).
The University of Oxford's Primary Care Clinical Trials Unit (PCCTU) is currently 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
The POS-ARI-PC study is a perpetual (long-lasting), observational study (POS), with the aim of describing the nature of acute respiratory tract infection (ARI) in adults and children presenting to primary care (PC) across Europe. Additionally, the study aims to establish a research-ready infrastructure for further studies to investigate how to treat, diagnose and prevent ARI. This approach makes it possible to set up new studies much faster.
Respiratory infections are one of the most common reasons for patients to visit their GP. Gaining a full understanding of the causes of respiratory infections, and how people with respiratory infections are treated and recover will help identify best practice, with the goal of ultimately improving patient care.
The PC-CTU is currently playing a leading role in the first "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 is an embedded study called POS-ARI-PC-001 which started in February 2024.
Respiratory viruses, like respiratory syncytial virus (RSV), human parainfluenza virus (HPIV), human metapneumovirus (HMPV) and rhinovirus (RV), seriously impact health during the winter season.
These viral respiratory infections often present like a common cold. But unlike a cold, such infections can progress to become a serious lung infection and cause complications like pneumonia and even death, particularly in high-risk patient groups. Sanofi is developing a combination vaccine that prevents infection and/or serious infection with these viruses.
This POS-ARI-PC-001 study will help to determine the incidence and health impact of these viruses in an older patient population in five European countries.
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 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 - May 2027
Who Can Participate?
You may be eligible to take part in the POS-ARI-PC-001 study at sites in the UK, France, Germany, Italy and Spain 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: Closed
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
-
Emma Harper
Trial Manager
-
Sarah Tonkin-Crine
Professor of Health Psychology
-
Fiona Mowbray
Qualitative Researcher
-
Sonya Beecher
Trial Coordinator
-
Rebecca Edeson
Trial Manager
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